Complicated skin and skin structure infection (cSSSI) with or without methicillin-resistant Staphylococcus aureus (MRSA) MedDRA version: 9.1 Level: LLT Classification code 10040872 Term: Skin infection MedDRA version: 9.1 Level: LLT Classification code 10066409 Term: Staphylococcal skin infection MedDRA version: 9.1 Level: LLT Classification code 10066412 Term: Staphylococcal aureus skin infection MedDRA version: 9.1 Level: LLT Classification code 10040872 Term: Skin infection MedDRA versio
Conditions
Sponsors
Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 8 to 17 years old. Children with bone maturation of less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration. 2. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 1 month after the last dose of any test article (a subject is biologically capable of having children even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives). 3. Presence of a cSSSI requiring hospitalization and administration of IV antibiotic therapy with anticipated length of IV antibiotic therapy greater than or equal to 5 days. 4. Have a cSSSI requiring significant surgical intervention or involving deeper soft tissue. This would include clinical entities such as one of the following (note that the following are examples): - infected wound; - infected decubitus ulcers (eg, perianal area); - burns (38.5 C or 13.5 x 109/L (13,500/mm3 for age 8 to 12), >11 x 109/L (11,000/mm3 for age 13 to 17), 10% immature neutrophils (bands); - positive blood culture; - any 2 of the following: systolic blood pressure 130 beats/min (age 8 to 12) or >110 beats/min (age 13 to 17), or respiratory rate >18 breaths/min (age 8 to 12) or >14 breaths/min (age 13 to 17). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with any concomitant illness/condition or taking any concomitant medication 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 (eg, life expectancy 5 x upper limit of normal (ULN); - Bilirubin >3 x ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the relative safety and efficacy of tigecycline versus clindamycin (including subjects treated with vancomycin) in the treatment of pediatric subjects (ages 8 to 17 years) with cSSSI including those caused by MRSA.;Secondary Objective: 1. To evaluate the microbiologic efficacy of tigecycline in the pediatric population. 2. To evaluate the PK/PD profile of tigecycline in pediatric subjects with cSSSI. 3. To obtain in vitro susceptibility data on tigecycline for a range of bacterial pathogens isolated from cSSSI.;Primary end point(s): The primary efficacy endpoint will be the clinical response rate at the TOC visit for 2 co-primary populations: the CE population and the c-mITT population. The clinical response will be determined by the investigator at the TOC assessment, and one of the following outcomes will be assigned: cure, failure, or indeterminate. | — |
Countries
Belgium, Hungary, United Kingdom
Outcome results
None listed