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Sponsored by: |
Cubist Pharmaceuticals |
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Information provided by: | Cubist Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00679835 |
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).
Condition | Intervention | Phase |
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Gram Positive Infection Concurrent Antibiotic Treatment |
Drug: daptomycin |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | 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 |
Estimated Enrollment: | 24 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
8 mg/kg over a one hour infusion
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Drug: daptomycin
i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
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Group 2: Experimental
10mg/kg over a one or two hour infusion
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Drug: daptomycin
i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
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Ages Eligible for Study: | 2 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Clarke | 781-860-8660 | andrea.clarke@cubist.com |
United States, Missouri | |
Children's Mercy Hospital | Recruiting |
Kansas City, Missouri, United States, 64108 |
Responsible Party: | Cubist Pharmaceuticals Inc ( Ed Campanaro ) |
Study ID Numbers: | DAP-PEDS-07-02 |
Study First Received: | May 15, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00679835 |
Health Authority: | United States: Food and Drug Administration |
Daptomycin |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |