Clinical trial NCT02607618: Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Official title: A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Structures and Soft Tissue Infections
Lead sponsor: Motif Bio
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
timeFrame: Baseline and 48 to 72 hours after first dose of study drug
Secondary outcomes:
measure: Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit
timeFrame: 7 to14 days after the end of treatment
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: California
state: California
city: Buena Park
country: United States
facility: California
state: California
city: Chula Vista
country: United States
facility: California
state: California
city: La Palma
country: United States
facility: California
state: California
city: Long Beach
country: United States
facility: California
state: California
city: Long Beach
country: United States
facility: St. Mary Medical Center ER
state: California
city: Hollywood
country: United States
facility: Florida
state: Florida
city: Miami
country: United States
facility: Florida
state: Florida
city: Miami
country: United States
facility: Florida
state: Florida
city: Columbus
country: United States
facility: Georgia
state: Georgia
city: Butte
country: United States
facility: Montana
state: Montana
city: Las Vegas
country: United States
facility: Nevada
state: Nevada
city: Somers Point
country: United States
facility: New Jersey
state: New Jersey
city: Lima
country: United States
facility: Ohio
state: Ohio
city: Smyrna
country: United States
facility: Tennessee
state: Tennessee
city: Kennewick
country: United States
facility: Washington
state: Washington
city: Richland
country: United States
facility: Washington
state: Washington
city: Buenos Aires
country: Argentina
facility: Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Argentina
city: Brussels
country: Belgium
facility: Belgium
city: Brussels
country: Belgium
facility: Belgium
city: Slavonski Brod
country: Croatia
facility: Croatia
city: Zadar
country: Croatia
facility: Croatia
city: Zagreb
country: Croatia
facility: Croatia
city: Hradec Kralove
country: Czechia
facility: Czech Republic
city: Ostrava
country: Czechia
facility: Czech Republic
city: Pribram
country: Czechia
facility: Czech Republic
city: Usti nad Labem
country: Czechia
facility: Czech Republic
city: Kohtla-Jarve
country: Estonia
facility: Estonia
city: Tallinn
country: Estonia
facility: Estonia
city: Tallinn
country: Estonia
facility: Estonia
city: Tartu
country: Estonia
facility: Estonia
city: Voru
country: Estonia
facility: Estonia
city: Budapest
country: Hungary
facility: Hungary
city: Miskolc
country: Hungary
facility: Hungary
city: Szeged
country: Hungary
facility: Hungary
city: Szekesfehervar
country: Hungary
facility: Hungary
city: Veszprem
country: Hungary
facility: Hungary
city: Amadora
country: Portugal
facility: Portugal
city: Braga
country: Portugal
facility: Portugal
city: Porto
country: Portugal
facility: Portugal
city: Santarem
country: Portugal
facility: Portugal
city: Viana do Castelo
country: Portugal
facility: Portugal
city: Arad
country: Romania
facility: Romania
city: Bucharest
country: Romania
facility: Romania
city: Bucharest
country: Romania
facility: Romania
city: Bucuresti
country: Romania
facility: Romania
city: Bucuresti
country: Romania
facility: Romania
city: Cluj-Napoca
country: Romania
facility: Romania
city: Craiova
country: Romania
facility: Romania
city: Timisoara
country: Romania
facility: Romania
city: Aydin
country: Turkey
facility: Turkey
city: Istanbul
country: Turkey
facility: Turkey
city: Trabzon
country: Turkey
facility: Turkey
Study officials:
affiliation: Motif Biosciences
name: Stephanie Noviello, MD
role: STUDY_DIRECTOR
References:
citation: Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19.
citation: Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May.