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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
50 mg IV every 12 hours up to 14 days
For clindamycin 10mg/kg (not to exceed 900mg) IV every 8 hours up to 14 days. For vancomycin 15mg/kg (not to exceed 2g/day and adjusted as needed for renal impairment) IV every 8 hours
Clinical response rate at the test-of-cure visit for the 2 co-primary populations: clinically evaluable and clinically modified intent to treat populations
Time frame: 15-37 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
Time frame: 5-49 days
Clinical cure rates by baseline pathogen (including MRSA) at test-of-cure (TOC) visit
Time frame: 15-37 days
Clinical response and microbiological response at the subject level for subjects with monomicrobial and polymicrobial infections at test-of-cure (TOC) visit
Time frame: 15-37 days
Development of decreased susceptibility
Time frame: 5-50 days
Clinical response and microbial response at subject level by baseline pathogen and minimum inhibitory concentration (MIC) values at test-of-cure (TOC) visit
Time frame: 15-37 days
Susceptibility data by pathogen
Time frame: 5-50 days
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