Status:
COMPLETED
Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Gram-positive Bacterial Infections
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2006
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00136292
Start Date
August 24 2005
End Date
August 9 2006
Last Update
March 11 2020
Active Locations (3)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
2
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
3
University of Texas Southwestern
Dallas, Texas, United States, 75390