PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
Phase 1
Completed
- Conditions
- Gram Positive InfectionConcurrent Antibiotic Treatment
- Interventions
- Registration Number
- NCT00679835
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief Summary
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;
- Male or female between the ages of 2 and 6 years old, inclusive;
- Able to comply with the protocol for the duration of the study;
- Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;
- Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;
- A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;
- Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.
- Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.
Exclusion Criteria
- Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
- Known allergy/ hypersensitivity to daptomycin;
- History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
- Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
- Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator;
- Administration of rifampin within 7 days of study drug administration;
- Body mass index (BMI) that is outside of the 5th to 95th percentile;
- Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
- History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
- Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;
- Expected surgical procedure(s) within 24 hours prior to and following dosing;
- Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;
- History of or current rhabdomyolysis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 daptomycin 8 mg/kg over a one hour infusion Group 2 daptomycin 10mg/kg over a one or two hour infusion
- Primary Outcome Measures
Name Time Method Pharmocokinetics of daptomycin From pre-dose to 24 hours post-dose
- Secondary Outcome Measures
Name Time Method Safety of daptomycin Up to 9 days after dosing
Trial Locations
- Locations (1)
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States