Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

ID: NCT00638157
Status: Terminated
Phase: Phase 4
Start Date: March 01, 2008
First Submitted: March 12, 2008
Last Updated: January 05, 2016
Results: Available
Success Rate: 54%
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: United States
Conditions: Infective Endocarditis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

Brief Summary

multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE

Detailed Description

Patients will be randomized to either of the following two treatment arms:

- Arm 1: daptomycin

- Arm 2: daptomycin with initial i.v. gentamicin

Patients who meet all the inclusion criteria and exhibit none of the exclusion criteria may be enrolled. Intravenous drug user (IVDU) patients may be randomized and study drug begun on the basis of two separate peripheral blood cultures positive for S. aureus obtained within 96 hours prior to the first dose of study drug.

The recommended minimum duration of treatment for daptomycin will be 28 days. The duration of treatment for gentamicin will be 3 days.

During study treatment, regular assessments (including weekly safety laboratory testing including CPK) will be performed. An End-of-Therapy (EOT) evaluation will be performed on the day of or 1-2 days after completion of daptomycin study drug or upon early termination (ET). All patients will have a post-therapy visit for Test of Cure (TOC)/Safety performed 21-28 days following the last dose of daptomycin study drug.
Condition or disease Intervention/treatment Phase

Infective Endocarditis

Drug: daptomycin
Other Names
Cubicin daptomycin for injection
Drug: daptomycin and gentamicin
Other Names
Cubicin daptomycin for injection gentamicin
Phase 4

Tracking Information

First Submitted DateMarch 12, 2008
Last Update Posted DateJanuary 05, 2016
Start DateMarch 01, 2008
Actual Completion DateNovember 01, 2011
Primary Completion DateNovember 01, 2011
Results First Submitted DateMarch 04, 2013
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Summary of Clinically Significant Increases in Serum Creatinine by Visit [Time Frame: Baseline, EOT Visit, TOC]

    The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.

Original Primary Outcome Measures

  • Summary of Clinically Significant Increases in Serum Creatinine by Visit

    The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.

Current Secondary Outcome Measures

  • Summary of the Investigator's Assessment of Clinical Response at the TOC Visit [Time Frame: TOC Visit]

    TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.

Original Secondary Outcome Measures

  • Summary of the Investigator's Assessment of Clinical Response at the TOC Visit

    TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.

Study Design

Brief TitlePhase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
Official TitleA Phase 4 Multicenter, Randomized, Double Blind Study to Describe the Efficacy and Safety of Cubicin® (Daptomycin for Injection) With and Without Initial Gentamicin Combination Therapy in the Treatment of S. Aureus Infective Endocarditis
Brief Summary

multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE

Detailed Description

Patients will be randomized to either of the following two treatment arms:

- Arm 1: daptomycin

- Arm 2: daptomycin with initial i.v. gentamicin

Patients who meet all the inclusion criteria and exhibit none of the exclusion criteria may be enrolled. Intravenous drug user (IVDU) patients may be randomized and study drug begun on the basis of two separate peripheral blood cultures positive for S. aureus obtained within 96 hours prior to the first dose of study drug.

The recommended minimum duration of treatment for daptomycin will be 28 days. The duration of treatment for gentamicin will be 3 days.

During study treatment, regular assessments (including weekly safety laboratory testing including CPK) will be performed. An End-of-Therapy (EOT) evaluation will be performed on the day of or 1-2 days after completion of daptomycin study drug or upon early termination (ET). All patients will have a post-therapy visit for Test of Cure (TOC)/Safety performed 21-28 days following the last dose of daptomycin study drug.

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
24
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Infective Endocarditis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: daptomycin

Intravenous (i.v.) 6 mg/kg q24h

Other Names
Cubicin
daptomycin for injection
Drug: daptomycin and gentamicin

i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin

Other Names
Cubicin
daptomycin for injection
gentamicin
Study Groups/Cohorts
Daptomycin Alone
daptomycin 6 mg/kg q24h for treatment of right-sided infective endocarditis

Daptomycin plus gentamicin
daptomycin 6 mg/kg q24h with concomitant initial gentamicin dosed for the first 2 days of therapy for the treatment of right-sided infective endocarditis

Study Arms
Active Comparator Daptomycin Alone
daptomycin 6 mg/kg q24h for treatment of right-sided infective endocarditis
Drug : daptomycin
Intravenous (i.v.) 6 mg/kg q24h

Experimental Daptomycin plus gentamicin
daptomycin 6 mg/kg q24h with concomitant initial gentamicin dosed for the first 2 days of therapy for the treatment of right-sided infective endocarditis
Drug : daptomycin and gentamicin
i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin

Arm Intervention/Treatment
Active Comparator Daptomycin Alone
daptomycin 6 mg/kg q24h for treatment of right-sided infective endocarditis
Drug : daptomycin
Experimental Daptomycin plus gentamicin
daptomycin 6 mg/kg q24h with concomitant initial gentamicin dosed for the first 2 days of therapy for the treatment of right-sided infective endocarditis
Drug : daptomycin and gentamicin

Recruitment Information

Recruitment Status:Terminated
Enrollment24
Completion DateNovember 01, 2011
Eligibility Criteria: Inclusion Criteria:
1. Written informed consent has been obtained;
2. Male or female ≥18 years of age;
3. IVDU (as confirmed by history of drug abuse within the past 3 months or recent needle track marks);
4. Definite or possible IE according to the modified Duke Criteria (see Appendix A); [17 ];
5. Two blood cultures positive for S. aureus obtained within 96 hours prior to first dose of study medication acquired by fresh venipuncture using aseptic technique and analyzed at the local laboratory (see Appendix B).

Exclusion Criteria:
1. Intravascular foreign material in place at the time that the positive blood culture was drawn (e.g., intracardiac pacemaker wires, percutaneous or implanted venous catheters, vascular grafts), (exception: vascular stents that have been in place for >6 months or permanent pacemaker wires attached via epicardial leads are allowed);
2. High likelihood of LIE as indicated by:
1. Prior diagnosis of predisposing left-sided valvular pathology (e.g., rheumatic heart disease, bicuspid aortic valve); or
2. Findings on screening examination of left-sided valvular pathology (e.g., diastolic murmur of aortic insufficiency); or
3. Findings on screening examination of major systemic emboli to visceral organs (e.g. cerebral or splenic infarct). Patients may be included if their only findings are consistent with microvascular phenomena due to immune complexes (e.g., splinter hemorrhages, conjunctival petechiae, Roth's spots, Osler's nodes, Janeway's lesions, microhematuria).
Note: Any patient enrolled in the study that is subsequently found to have LIE may be continued in the trial if determined to be clinically improving by the Investigator.
3. Prosthetic heart valve;
4. Baseline Creatinine clearance of <30 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight);
5. Baseline CPK value 5 X upper limit of normal (ULN) in conjunction with symptoms of myalgia or baseline CPK value 10 X ULN without symptoms;
6. Alanine aminotransferase (ALT) >5 X ULN;
7. Aspartate aminotransferase (AST) >5 X ULN;
8. Moribund clinical condition (i.e. high likelihood of death within 3 days after randomization);
9. Shock or hypotension (supine systolic blood pressure <80 mm Hg) or oliguria (urine output <20 mL/h) unresponsive to fluids or pressors within 4 hours;
10. Known pneumonia or osteomyelitis;
11. Polymicrobial infection or bacteremia due to a pathogen other than S. aureus;
12. Neutropenia (absolute neutrophil count < 0.5 X 103/μL) and/or lymphopenia (CD4 lymphocytes <0.2X 103/μL);
13. Anticipated to require non-study antibiotics that may be potentially effective against S. aureus;
14. Prior gentamicin therapy > 1 day;
15. Documented history of significant allergy or intolerance to any of the study medications;
16. Unlikely to comply with study procedures;
17. Pregnant or nursing. All females with childbearing potential will have a pregnancy test performed at the local laboratory.
18. Female of childbearing potential and not willing to practice barrier methods of birth control (e.g., condoms or diaphragms together with spermicidal foam or gel) during treatment and for at least 28 days after treatment with study medication
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00638157
Other Study ID Numbers
3009-010
DAP-4IE-06-03
Has Data Monitoring CommitteeNo
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
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Paula Bokesch, M.D.
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

TitleDescription
Daptomycin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
Daptomycin Plus Gentamicin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Participant Flow: Overall

DaptomycinDaptomycin Plus Gentamicin
1012
Started1212
Completed58
Not Completed74
Adverse Event01
Clinical (symptomatic) failure11
Lost to Follow-up10
Microbiological failure10
Not Specified12
Physician Decision10
Randomized, not treated20

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.
Intent-to-Treat (ITT) Population used. Includes all randomized subjects.

Reporting Groups

TitleDescription
Daptomycin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy.
Daptomycin Plus Gentamicin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
Total
Total of all reporting groups

Baseline Measures

DaptomycinDaptomycin Plus GentamicinTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
121224
121224
Age
Units: years - Mean (Standard Deviation)
Participants Analyzed
121224
38.9 (10.93)45.3 (9.90)42.1 (10.71)
Gender
Units: participants - Number
Participants Analyzed
121224
Female358
Male9716

Outcome Measures

1. Primary: Summary of Clinically Significant Increases in Serum Creatinine by Visit

Measure Type
Primary
Measure Title
Summary of Clinically Significant Increases in Serum Creatinine by Visit
Measure Description
The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.
Time Frame
Baseline, EOT Visit, TOC

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.
Safety Population includes all patients who received any dose of study medication.

Reporting Groups

TitleDescription
Daptomycin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
Daptomycin Plus Gentamicin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Outcome Measures

DaptomycinDaptomycin Plus Gentamicin
Participants Analyzed
Units: Participants
1012
Summary of Clinically Significant Increases in Serum Creatinine by Visit
Units: Participants - Number
Baseline - Any Elevation00
Baseline - No Elevation1012
End of Therapy - Any Elevation02
End of Therapy - No Elevation1010
Test of Cure - Any Elevation (n=8,9)02
Test of Cure - No Elevation (n=8,9)87

2. Secondary: Summary of the Investigator's Assessment of Clinical Response at the TOC Visit

Measure Type
Secondary
Measure Title
Summary of the Investigator's Assessment of Clinical Response at the TOC Visit
Measure Description
TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.
Time Frame
TOC Visit

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.
Modified Intent-to-Treat (mITT) population includes all ITT patients who received at least one dose of study medication.

Reporting Groups

TitleDescription
Daptomycin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy.
Daptomycin Plus Gentamicin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Outcome Measures

DaptomycinDaptomycin Plus Gentamicin
Participants Analyzed
Units: Participants
911
Summary of the Investigator's Assessment of Clinical Response at the TOC Visit
Units: Participants - Number
Non-evaluable22
TC (clinical cure, microbiological nonevaluable)00
TC (clinical cure, microbiological success)45
TF (clinical cure, microbiological failure)00
TF (clinical failure, microbiological failure)20
TF (clinical failure, microbiological nonevaluable02
TF (clinical failure, microbiological success)11
TF (clinical improved, microbiological failure)00
TI (clin improved, microbiological nonevaluable)00
TI (clinical improved, microbiological success)01

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Daptomycin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy.
Daptomycin Plus Gentamicin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Serious Adverse Events

DaptomycinDaptomycin Plus Gentamicin
Total, serious adverse events
No. of participants affected / at risk2/10 (0.00%)5/12 (0.00%)
Tachycardia
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Gastrointestinal haemorrhage
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Arthritis bacterial
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Bacteraemia
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Endocarditis
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Osteomyelitis
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Septic shock
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Renal failure
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Haemoptysis
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Rash
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Hypertension
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold5% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Daptomycin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy.
Daptomycin Plus Gentamicin
Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Other Adverse Events

DaptomycinDaptomycin Plus Gentamicin
Total, other adverse events
No. of participants affected / at risk8/10 (0.00%)11/12 (0.00%)
Anaemia
No. of participants affected / at risk2/10 (0.00%)1/12 (0.00%)
Splenomegaly
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Hypoacusis
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Abnormal sensation in eye
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Eye pain
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Vision blurred
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Constipation
No. of participants affected / at risk4/10 (0.00%)3/12 (0.00%)
Diarrhoea
No. of participants affected / at risk0/10 (0.00%)2/12 (0.00%)
Nausea
No. of participants affected / at risk1/10 (0.00%)2/12 (0.00%)
Umbilical hernia
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Vomiting
No. of participants affected / at risk1/10 (0.00%)1/12 (0.00%)
Catheter related complication
No. of participants affected / at risk3/10 (0.00%)1/12 (0.00%)
Chest discomfort
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Chills
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Influenza like illness
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Malaise
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Non-cardiac chest pain
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Oedema peripheral
No. of participants affected / at risk2/10 (0.00%)0/12 (0.00%)
Pyrexia
No. of participants affected / at risk2/10 (0.00%)0/12 (0.00%)
Bacterial sepsis
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Escherichia urinary tract infection
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Fungal skin infection
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Hepatitis C
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Osteomyelitis
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Paronychia
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Contusion
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Procedural pain
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Wound
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Aspartate aminotransferase increased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Blood creatine phosphokinase increased
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Blood creatinine increased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Blood glucose increased
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Cardiac murmur
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Haematocrit decreased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Haemoglobin decreased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Hepatic enzyme increased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Red blood cell count decreased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
White blood cell count increased
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Diabetes mellitus inadequate control
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Hyperkalaemia
No. of participants affected / at risk1/10 (0.00%)2/12 (0.00%)
Hyperphosphataemia
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Hypokalaemia
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Hypomagnesaemia
No. of participants affected / at risk2/10 (0.00%)2/12 (0.00%)
Muscle spasms
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Musculoskeletal pain
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Neck pain
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Pain in extremity
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Dysgeusia
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Headache
No. of participants affected / at risk2/10 (0.00%)0/12 (0.00%)
Somnolence
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Agitation
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Anxiety
No. of participants affected / at risk4/10 (0.00%)1/12 (0.00%)
Insomnia
No. of participants affected / at risk1/10 (0.00%)1/12 (0.00%)
Renal impairment
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Urinary incontinence
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Dyspnoea
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Nasal congestion
No. of participants affected / at risk2/10 (0.00%)0/12 (0.00%)
Dry skin
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Skin lesion
No. of participants affected / at risk0/10 (0.00%)1/12 (0.00%)
Skin ulcer
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)
Hypertension
No. of participants affected / at risk1/10 (0.00%)1/12 (0.00%)
Hypotension
No. of participants affected / at risk1/10 (0.00%)1/12 (0.00%)
Phlebitis
No. of participants affected / at risk1/10 (0.00%)0/12 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.
The first publication is initiated by Cubist. If First Publication not published within 1 year of Study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Ed Campanaro / Vice President, Clinical Operations
Cubist Pharmaceuticals
781-860-8318