Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections

ID: NCT00711802

Status: Completed

Phase: Phase 4

Start Date: July 23, 2008

First Submitted: July 07, 2008

Last Updated: May 26, 2017

Results: Available

Success Rate: 88%

Organization: Cubist Pharmaceuticals LLC

Sponsors & Collaborators: Cubist Pharmaceuticals LLC

Location: India, Panama, United States

Conditions: Skin Diseases, Infectious

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Study Details
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Study Description

Brief Summary

This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.

Detailed Description

This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years, inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into age groups and given age-dependent doses over a period of up to 14 days. Participants will be stratified by age group to receive either daptomycin or SOC (recommended as vancomycin, clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may continue on oral therapy following completion of IV study drug administration and provided that the participant meets all criteria for conversion to oral therapy, including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator. February 11, 2015 released from post marketing requirement to include subjects aged 3 months - < 1 year. Ref ID: 3701325

Condition or disease	Intervention/treatment	Phase
Skin Diseases, Infectious	Drug: Daptomycin Other Names Cubicin Drug: Standard of Care (SOC) Other Names nafcillin, oxacillin, cloxacillin	Phase 4

Tracking Information

First Submitted Date	July 07, 2008
Last Update Posted Date	May 26, 2017
Actual Start Date	July 23, 2008
Actual Completion Date	October 11, 2013
Actual Primary Completion Date	October 11, 2013
Results First Submitted Date	May 27, 2015
Received Results Disposit Date	N/A

Current Primary Outcome Measures

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline through 14 days after last dose of study drug]
A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Original Primary Outcome Measures

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Current Secondary Outcome Measures

Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit [Time Frame: Baseline through 14 days after last dose of study drug]
The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of "Failure" was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was "Failure." If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate."
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t]) [Time Frame: Predose and 5 timepoints according to age group (up to 12 hours postdose)]
Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points: Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion.

Original Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points: Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion.
Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of â€œFailureâ€ was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was â€œFailure.â€ If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate."

Study Design

Brief Title	Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
Official Title	An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens
Brief Summary	This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.
Detailed Description	This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years, inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into age groups and given age-dependent doses over a period of up to 14 days. Participants will be stratified by age group to receive either daptomycin or SOC (recommended as vancomycin, clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may continue on oral therapy following completion of IV study drug administration and provided that the participant meets all criteria for conversion to oral therapy, including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator. February 11, 2015 released from post marketing requirement to include subjects aged 3 months - < 1 year. Ref ID: 3701325
Study Type	Interventional
Study Phase	Phase 4
Estimated Enrollment	396
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Single
Primary Purpose	Treatment
Conditions	Skin Diseases, Infectious
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: Daptomycin Other Names Cubicin Drug: Standard of Care (SOC) Other Names nafcillin, oxacillin, cloxacillin
Study Groups/Cohorts	Daptomycin Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages. Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min. Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min. Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg) Age Group 2 (for ages 7 to 11 years): 7 mg/kg Age Group 3 (for ages 2 to 6 years): 9 mg/kg Age Group 4 (for ages 1 to <2 years): 10 mg/kg Standard of Care (SOC) The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Study Arms	Experimental Daptomycin Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages. Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min. Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min. Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg) Age Group 2 (for ages 7 to 11 years): 7 mg/kg Age Group 3 (for ages 2 to 6 years): 9 mg/kg Age Group 4 (for ages 1 to <2 years): 10 mg/kg Drug : Daptomycin Active Comparator Standard of Care (SOC) The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Drug : Standard of Care (SOC)

Arm	Intervention/Treatment
Experimental Daptomycin Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages. Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min. Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min. Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg) Age Group 2 (for ages 7 to 11 years): 7 mg/kg Age Group 3 (for ages 2 to 6 years): 9 mg/kg Age Group 4 (for ages 1 to <2 years): 10 mg/kg	Drug : Daptomycin
Active Comparator Standard of Care (SOC) The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.	Drug : Standard of Care (SOC)

Arm

Intervention/Treatment

Experimental Daptomycin

Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages. Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min. Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min. Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg) Age Group 2 (for ages 7 to 11 years): 7 mg/kg Age Group 3 (for ages 2 to 6 years): 9 mg/kg Age Group 4 (for ages 1 to <2 years): 10 mg/kg

Drug : Daptomycin

Active Comparator Standard of Care (SOC)

The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Drug : Standard of Care (SOC)

Recruitment Information

Recruitment Status:	Completed
Enrollment	396
Completion Date	October 11, 2013
Eligibility Criteria:	Inclusion Criteria: - Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care - Written participant assent (as appropriate) - Male or female between the ages of 1 and 17 years old, inclusive - If female of childbearing potential (defined as post-menarche), not lactating or pregnant, documented negative pregnancy test result within 48 hours prior to study medication administration and willing to practice reliable birth control measures (at the discretion of the Principal Investigator) during study treatment and for at least 28 days after study completion - Able to comply with the protocol for the duration of the study - Skin and skin structure infections of a complicated nature known or suspected to be caused by Gram-positive pathogen(s) that require IV antibiotic treatment. Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (such as, infected ulcers, burns, and major abscesses) or infections in which the participant has a significant underlying disease state that complicates the response to treatment. The Investigator may contact the Medical Monitor to discuss infections not meeting this definition but which otherwise appear appropriate for inclusion - At least three of the following clinical signs and symptoms associated with the cSSSI: pain; tenderness to palpation; temperature >37.5 degrees Celsius (C) (99.5 degrees Fahrenheit [F]) oral or >38 degrees C (100.4 degrees F) rectal; white blood count (WBC) >12,000/cubic millimeter (mm^3) or â‰¥10% bands; swelling and/or induration; erythema (>1 centimeter [cm] beyond edge of wound or abscess); or pus formation Exclusion Criteria: - Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry - Known allergy/hypersensitivity to daptomycin - Known infection caused solely by Gram-negative pathogen(s), fungus(i), or virus(es) - Previous systemic antimicrobial therapy exceeding 24 hours in duration administered anytime during the 48 hours prior to the first dose of study drug (exception: a participant is eligible if on previous antibiotics without any clinical improvement and/or a wound culture is available and the pathogen is not sensitive to prior therapy) - Known or suspected pneumonia, osteomyelitis, meningitis, or endocarditis - Known bacteremia (exception: any participant enrolled in the study that is subsequently found to have a blood culture positive for bacteremia may be continued) - Participant with current or known clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]) that would expose the participant to unacceptable risk as determined by Investigator - History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological, autoimmune disease, or primary immune deficiency (unless the Investigator considers that the subject would not be at risk by participating in the study [Note: human immunodeficiency virus-infected participants must not be enrolled]) - History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system, or seizure disorder - Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre syndrome or spinal cord injury - Known or suspected renal insufficiency (that is, estimated creatinine clearance rate [CLcr]<80 mL/min/1.73 squared meter [m^2] - History of or current rhabdomyolysis - History of (within 1 year prior to first dose of study drug) or current myositis - Current septic shock - Known or suspected creatine phosphokinase (CPK) elevation
Gender	All
Age	1 Year to 17 Years
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	India Panama United States Guatemala South Africa

Administrative Information

NCT Number:	NCT00711802
Other Study ID Numbers	3009-017 DAP-PEDS-07-03
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
Responsible Party	,
Study Sponsor	Cubist Pharmaceuticals LLC
Collaborators	Not Available
Investigators	Study Director Ellie Hershberger Cubist Pharmaceuticals LLC

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Not Available

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 1: Standard of Care (SOC)	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 2: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 3: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Age Group 4: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years

Participant Flow: Overall

	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
	73	37	73	38	81	42	30	15
Started	75	38	75	38	83	42	30	15
Completed	73	32	69	35	69	34	25	13
Not Completed	2	6	6	3	14	8	5	2
Adverse Event	0	0	0	0	1	1	0	0
Lost to Follow-up	0	0	3	1	10	6	4	2
Microbiological failure	0	1	0	0	0	1	0	0
Not treated (no further detail)	2	1	2	0	2	0	0	0
Physician Decision	0	2	0	0	0	0	0	0
Protocol Violation	0	0	0	1	0	0	0	0
Reason not reported	0	1	1	0	1	0	1	0
Withdrawal by Subject	0	1	0	1	0	0	0	0

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

All participants who received at least 1 dose of study drug

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 1: Standard of Care (SOC)	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 2: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 3: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Age Group 4: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years
Total	Total of all reporting groups

Baseline Measures

	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC	Total
Overall Participants Analyzed Units: Participants
Participants Analyzed	73	37	73	38	81	42	30	15	389
	73	37	73	38	81	42	30	15	389
Age Units: years - Mean (Standard Deviation)
Participants Analyzed	73	37	73	38	81	42	30	15	389
	15.02 (1.584)	14.84 (1.735)	9.05 (1.443)	8.98 (1.305)	3.92 (1.556)	3.86 (1.555)	1.46 (0.299)	1.43 (0.299)	8.21 (5.134)
Sex: Female, Male Units: Participants - Count of Participants
Participants Analyzed	73	37	73	38	81	42	30	15	389
Female	29	15	28	15	48	20	21	12	188
Male	44	22	45	23	33	22	9	3	201
Race (NIH/OMB) Units: Participants - Count of Participants
Participants Analyzed	73	37	73	38	81	42	30	15	389
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0
Asian	33	16	49	25	1	0	0	1	125
Black or African American	12	6	8	5	33	10	12	4	90
More than one race	0	0	0	1	0	1	0	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	1	1	0	4	0	0	1	7
White	28	14	15	7	43	31	18	9	165

Outcome Measures

1. Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Measure Type	Primary
Measure Title	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measure Description	A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame	Baseline through 14 days after last dose of study drug

Population Description

Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 1: Standard of Care (SOC)	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 2: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 3: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Age Group 4: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years

Outcome Measures

	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Participants Analyzed Units: Participants
	72	38	73	38	81	42	30	15
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Units: percentage of participants - Number
At least 1 drug-related TEAE	13.9	10.5	5.5	10.5	22.2	21.4	10.0	33.3
At least 1 TEAE	36.1	36.8	23.3	18.4	50.6	38.1	46.7	73.3
Discontinued treatment due to a TEAE	2.8	0	1.4	0	3.7	14.3	3.3	6.7

2. Secondary: Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit

Measure Type	Secondary
Measure Title	Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
Measure Description	The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of â€œFailureâ€ was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was â€œFailure.â€ If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate."
Time Frame	Baseline through 14 days after last dose of study drug

Population Description

Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 1: Standard of Care (SOC)	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 2: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 3: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Age Group 4: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years

Outcome Measures

	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Participants Analyzed Units: Participants
	73	37	73	38	81	42	30	15
Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit Units: percentage of participants - Number
Clinical failure	0	2.7	2.7	0	1.2	0	0	0
Clinical success	95.9	91.9	90.4	92.1	82.7	76.2	80.0	86.7
Unable to evaluate	4.1	5.4	6.9	7.9	16.1	23.8	20.0	13.3

3. Secondary: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])

Measure Type	Secondary
Measure Title	Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
Measure Description	Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points: Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion.
Time Frame	Predose and 5 timepoints according to age group (up to 12 hours postdose)

Population Description

Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years

Outcome Measures

	Age Group 1: Daptomycin	Age Group 2: Daptomycin	Age Group 3: Daptomycin	Age Group 4: Daptomycin
Participants Analyzed Units: Participants
	6	2	7	30
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t]) Units: microgramhour per milliliter (Î¼ghr/mL) - Mean (Standard Deviation)
	318 (62.2)	NA	318 (68.6)	466

Serious Adverse Events

Time Frame	Baseline through 14 days after last dose of study drug
Additional Description	Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
Frequency Threshold	0% (Threshold above which other adverse events are reported)

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 1: Standard of Care (SOC)	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 2: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 3: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Age Group 4: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years

Serious Adverse Events

	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Total, serious adverse events
No. of participants affected / at risk	3/72 (0.00%)	1/38 (0.00%)	1/73 (0.00%)	1/38 (0.00%)	2/81 (0.00%)	1/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Chest pain
No. of participants affected / at risk	1/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Pyrexia
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	1/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Abscess
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	1/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Bacteraemia
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	1/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Osteomyelitis
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	1/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Subcutaneous abscess
No. of participants affected / at risk	1/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Toxic shock syndrome
No. of participants affected / at risk	0/72 (0.00%)	1/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Blood creatine phosphokinase increased
No. of participants affected / at risk	1/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Myopathy
No. of participants affected / at risk	1/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Status asthmaticus
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Wound drainage
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	1/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)

Other Adverse Events

Time Frame	Baseline through 14 days after last dose of study drug
Additional Description	Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
Frequency Threshold	1% (Threshold above which other adverse events are reported)

Reporting Groups

Title	Description
Age Group 1: Daptomycin	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years
Age Group 1: Standard of Care (SOC)	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years
Age Group 2: Daptomycin	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years
Age Group 2: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years
Age Group 3: Daptomycin	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years
Age Group 3: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years
Age Group 4: Daptomycin	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Age Group 4: SOC	SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years

Other Adverse Events

	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Total, other adverse events
No. of participants affected / at risk	15/72 (0.00%)	9/38 (0.00%)	7/73 (0.00%)	2/38 (0.00%)	27/81 (0.00%)	10/42 (0.00%)	11/30 (0.00%)	11/15 (0.00%)
Cheilitis
No. of participants affected / at risk	0/72 (0.00%)	1/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Diarrhoea
No. of participants affected / at risk	3/72 (0.00%)	1/38 (0.00%)	3/73 (0.00%)	1/38 (0.00%)	12/81 (0.00%)	4/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Nausea
No. of participants affected / at risk	2/72 (0.00%)	0/38 (0.00%)	1/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Vomiting
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	1/73 (0.00%)	0/38 (0.00%)	4/81 (0.00%)	1/42 (0.00%)	2/30 (0.00%)	0/15 (0.00%)
Infusion site extravasation
No. of participants affected / at risk	1/72 (0.00%)	1/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Infusion site pain
No. of participants affected / at risk	1/72 (0.00%)	2/38 (0.00%)	1/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Pyrexia
No. of participants affected / at risk	2/72 (0.00%)	0/38 (0.00%)	4/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	1/42 (0.00%)	2/30 (0.00%)	3/15 (0.00%)
Abscess neck
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Candida nappy rash
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	1/30 (0.00%)	1/15 (0.00%)
Cellulitis
No. of participants affected / at risk	1/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	2/30 (0.00%)	0/15 (0.00%)
Fungal infection
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Genital candidiasis
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Hand-foot-and-mouth disease
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Rhinitis
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Upper respiratory tract infection
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	1/38 (0.00%)	0/81 (0.00%)	1/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Blood creatine phosphokinase increased
No. of participants affected / at risk	4/72 (0.00%)	2/38 (0.00%)	0/73 (0.00%)	1/38 (0.00%)	8/81 (0.00%)	2/42 (0.00%)	1/30 (0.00%)	2/15 (0.00%)
Blood phosphorus increased
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	1/30 (0.00%)	1/15 (0.00%)
Lymphocyte percentage increase
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Neutrophil count decreased
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Platelet count increased
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Red blood cells urine
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Hyperphosphataemia
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	0/42 (0.00%)	2/30 (0.00%)	0/15 (0.00%)
Headache
No. of participants affected / at risk	5/72 (0.00%)	3/38 (0.00%)	2/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	0/15 (0.00%)
Pharyngeal lesion
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	0/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Rhinorrhoea
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	1/38 (0.00%)	2/81 (0.00%)	0/42 (0.00%)	2/30 (0.00%)	0/15 (0.00%)
Dermatitis diaper
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	1/42 (0.00%)	2/30 (0.00%)	2/15 (0.00%)
Rash
No. of participants affected / at risk	0/72 (0.00%)	1/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	1/81 (0.00%)	2/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)
Rash papular
No. of participants affected / at risk	1/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	1/42 (0.00%)	2/30 (0.00%)	0/15 (0.00%)
Urticaria
No. of participants affected / at risk	0/72 (0.00%)	0/38 (0.00%)	0/73 (0.00%)	0/38 (0.00%)	0/81 (0.00%)	1/42 (0.00%)	0/30 (0.00%)	1/15 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Organization	Phone	Email
Vice President, Clinical Research	Cubist Pharmaceuticals	(781) 860-8660

Results Publications

Bradley J, Glasser C, Patino H, Arnold SR, Arrieta A, Congeni B, Daum RS, Kojaoghlanian T, Yoon M, Anastasiou D, Wolf DJ, Bokesch P. Daptomycin for Complicated Skin Infections: A Randomized Trial. Pediatrics. 2017 Mar;139(3). pii: e20162477. doi: 10.1542/peds.2016-2477. Epub 2017 Feb 15.