Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects

Phase 3

Withdrawn

• Conditions: Skin Diseases; Infection
• Interventions: Drug: Clindamycin (or Vancomycin if needed); Drug: Tigecycline

• Registration Number: NCT00911573
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The main purpose of this study is to compare the safety and efficacy of tigecycline versus clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17 years) with complicated skin and skin structure infections (cSSSI), including those caused by methicillin-resistant staphylococcus aureus (MRSA).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-02
• Study Start: 2011-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-07
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
• Have a diagnosis of a serious infection requiring hospitalization and administration of IV antibiotic therapy.
• complicated skin and skin structure infections (cSSSI) requiring significant surgical intervention or involving deeper soft tissue with the presence of at least one sign of systemic infection

Exclusion Criteria

• Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy < 30 days).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Clindamycin (or Vancomycin if needed)	Clindamycin (or Vancomycin if needed)
A	Tigecycline	Tigecycline

Primary Outcome Measures

Name	Time	Method
Clinical response rate at the test-of-cure visit for the 2 co-primary populations: clinically evaluable and clinically modified intent to treat populations	15-37 days

Secondary Outcome Measures

Name	Time	Method
Clinical response and microbiological response at the subject level for subjects with monomicrobial and polymicrobial infections at test-of-cure (TOC) visit	15-37 days
Clinical response and microbial response at subject level by baseline pathogen and minimum inhibitory concentration (MIC) values at test-of-cure (TOC) visit	15-37 days
Susceptibility data by pathogen	5-50 days
Microbiologic response at the subject level and at the pathogen level measured at intravenous last day of therapy (IV LDOT), test-of-cure (TOC) and follow-up (FUP) visits	5-49 days
Clinical cure rates by baseline pathogen (including MRSA) at test-of-cure (TOC) visit	15-37 days
Development of decreased susceptibility	5-50 days