Status:
COMPLETED
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Gram Positive Infection
Concurrent Antibiotic Treatment
Eligibility:
All Genders
2-6 years
Phase:
PHASE1
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 infectio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00679835
Start Date
June 3 2008
End Date
November 20 2008
Last Update
November 13 2019
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108