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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 1

Conditions: Gram-positive Bacterial Infections

Treatments: Drug: daptomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00136292

3009-028

DAP-PEDS-05-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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