Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

ID: NCT00136292
Status: Completed
Phase: Phase 1
Start Date: August 24, 2005
First Submitted: August 25, 2005
Last Updated: December 19, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: Chile, China
Conditions: Gram-positive Bacterial Infections
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Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Detailed Description

Condition or disease Intervention/treatment Phase

Gram-positive Bacterial Infections

Drug: daptomycin
Other Names
Phase 1

Tracking Information

First Submitted DateAugust 25, 2005
Last Update Posted DateDecember 19, 2017
Actual Start DateAugust 24, 2005
Actual Completion DateAugust 09, 2006
Actual Primary Completion DateAugust 01, 2006
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Pharmacokinetic

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Tolerability

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics
Official TitleAn Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection
Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
33
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None
Primary Purpose
Not Available
Conditions
Gram-positive Bacterial Infections
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: daptomycin

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment33
Completion DateAugust 09, 2006
Eligibility Criteria: Inclusion Criteria:
- 2-17 years old
- Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
- Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
- Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
- Creatine phosphokinase (CPK) levels within normal limits

Exclusion Criteria:
- Known allergy to daptomycin
- History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
- Pneumonia as sole gram-positive infection
- Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
- Clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]), as determined by Investigator
- Body mass index (BMI) that is outside of the 5th to 95th percentile for age
- History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
- Expected intramuscular (IM) injection within 3 days following dosing
- Expected surgical procedure(s) within 3 days following dosing
- Unexplained muscular weakness
- Rhabdomyolysis, myositis or septic shock
GenderAll
Age2 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00136292
Other Study ID Numbers
3009-028
DAP-PEDS-05-01
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
Principal Investigator
Richard Jacobs, MD
University of Arkansas