NCT00679835

PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gram Positive Infection
• Concurrent Antibiotic Treatment

Interventions

Type	Name	Description
DRUG	daptomycin	i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.

Timeline

• Start date: 2008-06-03
• Primary completion: 2008-11-20
• Completion: 2008-11-20
• First posted: 2008-05-19
• Last updated: 2019-11-13

Locations

1 site across 1 country: United States