Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2

• Status: Completed
• Trial end date: 2017-08-08
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Motif Bio
• Treatments: Iclaprim; Vancomycin

Criteria

Inclusion Criteria:

1. written informed consent;

2. ≥18 years of age;

3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;

2. infected diabetic foot ulcers;

3. infected decubitus ulcers;

4. necrotizing fasciitis or gangrene;

5. uncomplicated skin or skin structure infection;

6. infections associated with a prosthetic device;

7. suspected or confirmed osteomyelitis;

8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.