Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics
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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.
An 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
Actual Study Start Date :
August 24, 2005
Actual Primary Completion Date :
August 1, 2006
Actual Study Completion Date :
August 9, 2006
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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