Overview

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

Status:
Withdrawn
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Minocycline
Tigecycline
Vancomycin
Criteria
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).