Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

Wyeth

Status and phase: Completed; Phase 4

Conditions: Skin Diseases, Bacterial

Treatments: Drug: Tigecycline; Drug: ampicillin-sulbactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00368537

3074A1-900

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

Enrollment: 550 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of complicated skin or skin structure infection
• Male or female, 18 years or older
• Need for intravenous treatment for 4 to 14 days

Exclusion criteria

• Skin infection that can be treated by surgery & wound care alone
• Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
• Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

1

Active Comparator group

Description:

Arm 1: Tigecycline

Treatment:

Drug: Tigecycline

2

Active Comparator group

Description:

Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide

Treatment:

Drug: ampicillin-sulbactam