Clinical trial NCT02600611: Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
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-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Structures and Soft Tissue Infections
Lead sponsor: Motif Bio
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 600
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 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).

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: ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
timeFrame: Baseline and 48-72 hours after first dose of study drug
Secondary outcomes:
measure: Resolution or Near Resolution of Lesion at Test of Cure Visit
timeFrame: 7 to14 days after the end of treatment
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: California
state: California
city: La Mesa
country: United States
facility: California
state: California
city: Long Beach
country: United States
facility: California
state: California
city: Modesto
country: United States
facility: California
state: California
city: Oceanside
country: United States
facility: California
state: California
city: Torrance
country: United States
facility: California
state: California
city: Washington
country: United States
facility: District of Columbia
state: District of Columbia
city: DeLand
country: United States
facility: Florida
state: Florida
city: Miami
country: United States
facility: Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana
state: Indiana
city: Lincoln
country: United States
facility: Nebraska
state: Nebraska
city: Franklin
country: United States
facility: Tennessee
state: Tennessee
city: Franklin
country: United States
facility: Tennessee
state: Tennessee
city: Channelview
country: United States
facility: Texas
state: Texas
city: McAllen
country: United States
facility: Texas
state: Texas
city: Seattle
country: United States
facility: Washington
state: Washington
city: Sofia
country: Bulgaria
facility: Bulgaria
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Bulgaria
city: Temuco
country: Chile
facility: Chile
city: Barranquilla
country: Colombia
facility: Colombia
city: Koeln
country: Germany
facility: Germany
state: Northwest
city: Dessau
country: Germany
facility: Germany
city: Mainz
country: Germany
facility: Germany
city: Munster
country: Germany
facility: Germany
city: Daugavpils
country: Latvia
facility: Latvia
city: Liepaja
country: Latvia
facility: Latvia
city: Rezekne
country: Latvia
facility: Latvia
city: Riga
country: Latvia
facility: Latvia
city: Riga
country: Latvia
facility: Latvia
city: Cerro De Pasco
country: Peru
facility: Peru
state: LIM
city: Cusco
country: Peru
facility: Peru
city: Ica
country: Peru
facility: Peru
city: La Libertad
country: Peru
facility: Peru
city: Lima
country: Peru
facility: Peru
city: Lima
country: Peru
facility: Peru
city: Lima
country: Peru
facility: Peru
city: Piura
country: Peru
facility: Peru
city: San Borja
country: Peru
facility: Peru
city: San Juan de Miraflores
country: Peru
facility: Peru
city: Bydgoszcz
country: Poland
facility: Poland
city: Olsztyn
country: Poland
facility: Poland
city: Warszawa
country: Poland
facility: Poland
city: Wroclaw
country: Poland
facility: Poland
city: Ponce
country: Puerto Rico
facility: Puerto Rico
city: Rio Grande
country: Puerto Rico
facility: Puerto Rico
city: Cherkasy
country: Ukraine
facility: Ukraine
city: Ivano Frankivsk
country: Ukraine
facility: Ukraine
city: Ivano-Frankivsk
country: Ukraine
facility: Ukraine
city: Khar'kov
country: Ukraine
facility: Ukraine
city: Kharkiv
country: Ukraine
facility: Ukraine
city: Kiev
country: Ukraine
facility: Ukraine
city: Odessa
country: Ukraine
facility: Ukraine
city: Odessa
country: Ukraine
facility: Ukraine
city: Zaporizhzhya
country: Ukraine
facility: Ukraine
city: Zaporizhzhya
country: Ukraine
facility: Ukraine
city: Zaporizhzhya
country: Ukraine
facility: Ukraine
Study officials:
affiliation: Motif BioSciences
name: David Huang, MD, PhD
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: Huang DB, O'Riordan W, Overcash JS, Heller B, Amin F, File TM, Wilcox MH, Torres A, Dryden M, Holland TL, McLeroth P, Shukla R, Corey GR. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clin Infect Dis. 2018 Apr 3;66(8):1222-1229. doi: 10.1093/cid/cix987.