Infection, Skin Diseases
Conditions
Keywords
pediatry, children, skin, bacteria, MRSA
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).
Interventions
DRUGTigecycline
50 mg IV every 12 hours up to 14 days
DRUGClindamycin (or Vancomycin if needed)
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
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Susceptibility data by pathogen | 5-50 days |
| Development of decreased susceptibility | 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 | 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 | 15-37 days |
Outcome results
None listed