Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

Motif Bio

Status and phase: Completed; Phase 3

Conditions: Skin Structures and Soft Tissue Infections

Treatments: Drug: vancomycin; Drug: iclaprim

Study type: Interventional

Funder types: Industry

Identifiers

NCT02600611

ICL-23-ABSSSI1

Details and patient eligibility

About

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.

Full description

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

iclaprim

Experimental group

Description:

iclaprim 80 mg intravenous every 12 hours

Treatment:

Drug: iclaprim

vancomycin

Active Comparator group

Description:

vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance

Treatment:

Drug: vancomycin