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

Completed · Phase 3

Conditions studied: Skin Structures and Soft Tissue Infections

In brief

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.

Key facts

Study ID

NCT02607618

Run by

Motif Bio

People needed

613

Starts

2015-11-01

Expected to finish

2017-08-08

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• written informed consent;
• ≥18 years of age;
• a bacterial infection of the skin with a lesion size area of at least 75 cm2;
• a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
• the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

You may not qualify if…

• severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
• infected diabetic foot ulcers;
• infected decubitus ulcers;
• necrotizing fasciitis or gangrene;
• uncomplicated skin or skin structure infection;
• infections associated with a prosthetic device;
• suspected or confirmed osteomyelitis;
• conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.

Where it is running

• California — Buena Park, California, United States
• California — Chula Vista, California, United States
• California — La Palma, California, United States
• California — Long Beach, California, United States
• St. Mary Medical Center ER — Long Beach, California, United States
• Florida — Hollywood, Florida, United States
• Florida — Miami, Florida, United States
• Florida — Miami, Florida, United States
• Georgia — Columbus, Georgia, United States
• Montana — Butte, Montana, United States
• Nevada — Las Vegas, Nevada, United States
• New Jersey — Somers Point, New Jersey, United States
• Ohio — Lima, Ohio, United States
• Tennessee — Smyrna, Tennessee, United States
• Washington — Kennewick, Washington, United States
• Washington — Richland, Washington, United States
• Argentina — Buenos Aires, Argentina
• Argentina — Buenos Aires, Argentina
• Belgium — Brussels, Belgium
• Belgium — Brussels, Belgium
• Croatia — Slavonski Brod, Croatia
• Croatia — Zadar, Croatia
• Croatia — Zagreb, Croatia
• Czech Republic — Hradec Králové, Czechia
• California — Anaheim, California, United States

Full record on ClinicalTrials.gov

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