Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics
Phase 1
Completed
- Conditions
- Gram-positive Bacterial Infections
- Registration Number
- NCT00136292
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pharmacokinetic
- Secondary Outcome Measures
Name Time Method Tolerability
Trial Locations
- Locations (3)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Children's Mercy Hospitals and Clinics
🇺🇸Kansas City, Missouri, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States