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

Phase 3

Completed

• Conditions: Skin Structures and Soft Tissue Infections
• Interventions: Drug: Vancomycin; Drug: Iclaprim

• Registration Number: NCT02607618
• Lead Sponsor: Motif Bio

Brief 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.

Detailed Description

This is a multicenter, randomized, double-blind study of the efficacy and safety of IV iclaprim compared to IV 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).

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Primary Completion: 2017-08-08
• Study Completion: 2017-08-08
• Status Verified: 2018-06
• Results First Submitted: 2018-06-14
• Results First Submitted QC: 2018-06-14
• Last Update Submitted: 2018-07-10
• Results First Posted: 2018-07-11
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vancomycin	Vancomycin	vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
iclaprim	Iclaprim	iclaprim 80 mg intravenous every 12 hours

Primary Outcome Measures

Name	Time	Method
Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline	Baseline and 48 to 72 hours after first dose of study drug	≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit	7 to14 days after the end of treatment	Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.

Trial Locations

Locations (19)

St. Mary Medical Center ER; 🇺🇸 Long Beach, California, United States

California; 🇺🇸 Long Beach, California, United States

Georgia; 🇺🇸 Columbus, Georgia, United States

Croatia; 🇭🇷 Zagreb, Croatia

Czech Republic; 🇨🇿 Usti nad Labem, Czechia

Turkey; 🇹🇷 Trabzon, Turkey

Florida; 🇺🇸 Miami, Florida, United States

Ohio; 🇺🇸 Lima, Ohio, United States

Tennessee; 🇺🇸 Smyrna, Tennessee, United States

Montana; 🇺🇸 Butte, Montana, United States

Washington; 🇺🇸 Richland, Washington, United States

Nevada; 🇺🇸 Las Vegas, Nevada, United States

Portugal; 🇵🇹 Viana do Castelo, Portugal

Romania; 🇷🇴 Timisoara, Romania

Argentina; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina

Belgium; 🇧🇪 Brussels, Belgium

Hungary; 🇭🇺 Veszprem, Hungary

Estonia; 🇪🇪 Voru, Estonia

New Jersey; 🇺🇸 Somers Point, New Jersey, United States