Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
NCT ID: NCT02600611
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2015-11-01
2017-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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iclaprim
iclaprim 80 mg intravenous every 12 hours
iclaprim
Experimental treatment
vancomycin
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
vancomycin
Active comparator
Interventions
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iclaprim
Experimental treatment
vancomycin
Active comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Motif Bio
INDUSTRY
Responsible Party
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Principal Investigators
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David Huang, MD, PhD
Role: STUDY_DIRECTOR
Motif BioSciences
Locations
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California
Buena Park, California, United States
California
La Mesa, California, United States
California
Long Beach, California, United States
California
Modesto, California, United States
California
Oceanside, California, United States
California
Torrance, California, United States
District of Columbia
Washington D.C., District of Columbia, United States
Florida
DeLand, Florida, United States
Florida
Miami, Florida, United States
Indiana
Indianapolis, Indiana, United States
Nebraska
Lincoln, Nebraska, United States
Tennessee
Franklin, Tennessee, United States
Tennessee
Franklin, Tennessee, United States
Texas
Channelview, Texas, United States
Texas
McAllen, Texas, United States
Washington
Seattle, Washington, United States
Bulgaria
Sofia, Sofia-Grad, Bulgaria
Bulgaria
Sofia, , Bulgaria
Chile
Temuco, , Chile
Colombia
Barranquilla, , Colombia
Germany
Cologne, Northwest, Germany
Germany
Dessau, , Germany
Germany
Mainz, , Germany
Germany
Münster, , Germany
Latvia
Daugavpils, , Latvia
Latvia
Liepāja, , Latvia
Latvia
Rēzekne, , Latvia
Latvia
Riga, , Latvia
Latvia
Riga, , Latvia
Peru
Cerro de Pasco, LIM, Peru
Peru
Cusco, , Peru
Peru
Ica, , Peru
Peru
La Libertad, , Peru
Peru
Lima, , Peru
Peru
Lima, , Peru
Peru
Lima, , Peru
Peru
Piura, , Peru
Peru
San Borja, , Peru
Peru
San Juán de Miraflores, , Peru
Poland
Bydgoszcz, , Poland
Poland
Olsztyn, , Poland
Poland
Warsaw, , Poland
Poland
Wroclaw, , Poland
Puerto Rico
Ponce, , Puerto Rico
Puerto Rico
Río Grande, , Puerto Rico
Ukraine
Cherkasy, , Ukraine
Ukraine
Ivano-Frankivsk, , Ukraine
Ukraine
Ivano-Frankivsk, , Ukraine
Ukraine
Kharkiv, , Ukraine
Ukraine
Kharkiv, , Ukraine
Ukraine
Kiev, , Ukraine
Ukraine
Odesa, , Ukraine
Ukraine
Odesa, , Ukraine
Ukraine
Zaporizhzhya, , Ukraine
Ukraine
Zaporizhzhya, , Ukraine
Ukraine
Zaporizhzhya, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ICL-23-ABSSSI1
Identifier Type: -
Identifier Source: org_study_id
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