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| Sponsor: | Cubist Pharmaceuticals |
|---|---|
| Information provided by: | Cubist Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00711802 |
Purpose
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 2-17 years, inclusive, with cSSSI caused by Gram-positive pathogens.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Diseases, Infectious |
Drug: Daptomycin Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Two to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens |
| Estimated Enrollment: | 339 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Daptomycin: Experimental |
Drug: Daptomycin
i.v. daptomycin given at 5 mg/kg (ages 12-17 years); at 7 mg/kg (ages 7-11 years); or 9 mg/kg (ages 2-6 years)
|
|
Comparator: Active Comparator
Comparator recommended as vancomycin, clindamycin or semi-synthetic penicillin administered per standard of care
|
Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins
administered per Standard of Care
|
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 2-17 years, inclusive, with cSSSI caused by Gram-positive pathogens. Subjects will be enrolled into two age groups and given age dependant doses over a period of up to 14 days. Subjects will be stratified by age group to receive either daptomycin or standard of care (recommended as vancomycin, clindamycin or semi-synthetic penicillin) in a ratio of 2:1, respectively. Subjects may continue on oral therapy following completion of i.v. study drug administration and provided that the subject meets all criteria for conversion to oral therapy including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator.
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Andrea J Clarke | 781-860-8660 ext 8458 | andrea.clarke@cubist.com |
Show 40 Study Locations| Study Director: | Alistair Wheeler, MD | Cubist Pharmaceuticals |
More Information
| Responsible Party: | Cubist Pharmaceuticals, Inc. ( Ed Campanaro/Vice President, Clinical Operations ) |
| Study ID Numbers: | DAP-PEDS-07-03 |
| Study First Received: | July 7, 2008 |
| Last Updated: | January 31, 2010 |
| ClinicalTrials.gov Identifier: | NCT00711802 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Complicated Skin Structure |
|
Communicable Diseases Anti-Infective Agents Clindamycin Skin Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Pharmacologic Actions Daptomycin Protein Synthesis Inhibitors Anti-Bacterial Agents Skin Diseases, Infectious Therapeutic Uses Vancomycin |