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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600611
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Skin Structures and Soft Tissue Infections Drug: iclaprim Drug: vancomycin Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: iclaprim
iclaprim 80 mg intravenous every 12 hours
Drug: iclaprim
Experimental treatment
Other Name: MTF-100

Active Comparator: vancomycin
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Drug: vancomycin
Active comparator
Other Name: Vancocin




Primary Outcome Measures :
  1. ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. [ Time Frame: Baseline and 48-72 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 :
  1. Resolution or Near Resolution of Lesion at Test of Cure Visit [ Time Frame: 7 to14 days after the end of treatment ]
    Resolution or near resolution of lesion at Test of Cure (TOC) visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600611


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Locations
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United States, California
California
Buena Park, California, United States, 90620
California
La Mesa, California, United States, 91942
California
Long Beach, California, United States, 90806
California
Modesto, California, United States, 95350-449
California
Oceanside, California, United States, 92056
California
Torrance, California, United States, 90503
United States, District of Columbia
District of Columbia
Washington, District of Columbia, United States, 20017
United States, Florida
Florida
DeLand, Florida, United States, 32770-0834
Florida
Miami, Florida, United States, 33144
United States, Indiana
Indiana
Indianapolis, Indiana, United States, 46260
United States, Nebraska
Nebraska
Lincoln, Nebraska, United States, 68510-2462
United States, Tennessee
Tennessee
Franklin, Tennessee, United States, 37067
Tennessee
Franklin, Tennessee, United States, 37094
United States, Texas
Texas
Channelview, Texas, United States, 77530
Texas
McAllen, Texas, United States, 78503
United States, Washington
Washington
Seattle, Washington, United States, 98195
Bulgaria
Bulgaria
Sofia, Sofia-Grad, Bulgaria, 1431
Bulgaria
Sofia, Bulgaria, 1527
Chile
Chile
Temuco, Chile, 4781151
Colombia
Colombia
Barranquilla, Colombia, 80020
Germany
Germany
Koeln, Northwest, Germany, 50937
Germany
Dessau, Germany, 6847
Germany
Mainz, Germany, 55131
Germany
Munster, Germany, 48149
Latvia
Latvia
Daugavpils, Latvia, LV-5417
Latvia
Liepaja, Latvia, LV3414
Latvia
Rezekne, Latvia, 4600
Latvia
Riga, Latvia, LV-1002
Latvia
Riga, Latvia, LV-1038
Peru
Peru
Cerro De Pasco, LIM, Peru, 1
Peru
Cusco, Peru
Peru
Ica, Peru
Peru
La Libertad, Peru
Peru
Lima, Peru, 01
Peru
Lima, Peru, 29
Peru
Lima, Peru, 31
Peru
Piura, Peru
Peru
San Borja, Peru
Peru
San Juan de Miraflores, Peru, 29
Poland
Poland
Bydgoszcz, Poland, 85-094
Poland
Olsztyn, Poland, 10-229
Poland
Warszawa, Poland, 00-909
Poland
Wroclaw, Poland, 51-124
Puerto Rico
Puerto Rico
Ponce, Puerto Rico, 780
Puerto Rico
Rio Grande, Puerto Rico, 745
Ukraine
Ukraine
Cherkasy, Ukraine, 18009
Ukraine
Ivano Frankivsk, Ukraine, 7608
Ukraine
Ivano-Frankivsk, Ukraine, 76014
Ukraine
Khar'kov, Ukraine, 6100
Ukraine
Kharkiv, Ukraine, 61037
Ukraine
Kiev, Ukraine, 3110
Ukraine
Odessa, Ukraine, 65025
Ukraine
Odessa, Ukraine, 65082
Ukraine
Zaporizhzhya, Ukraine, 69000
Ukraine
Zaporizhzhya, Ukraine, 69032
Ukraine
Zaporizhzhya, Ukraine, 69065
Sponsors and Collaborators
Motif Bio
Investigators
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Study Director: David Huang, MD, PhD Motif BioSciences
  Study Documents (Full-Text)

Documents provided by Motif Bio:
Study Protocol  [PDF] December 3, 2015
Statistical Analysis Plan  [PDF] March 23, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Motif Bio
ClinicalTrials.gov Identifier: NCT02600611     History of Changes
Other Study ID Numbers: ICL-23-ABSSSI1
First Posted: November 9, 2015    Key Record Dates
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Soft Tissue Infections
Infection
Vancomycin
Iclaprim
Anti-Bacterial Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action