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

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. Identifier: NCT02607618
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : July 11, 2018
Last Update Posted : August 7, 2018
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 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 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-2
Study Start Date : November 2015
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 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. Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline [ Time Frame: 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 :
  1. Number of Participants With 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

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 identifier (NCT number): NCT02607618

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Sponsors and Collaborators
Motif Bio
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Study Director: Stephanie Noviello, MD Motif Biosciences
  Study Documents (Full-Text)

Documents provided by Motif Bio:
Study Protocol  [PDF] December 3, 2015
Statistical Analysis Plan  [PDF] July 24, 2017

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Motif Bio Identifier: NCT02607618    
Other Study ID Numbers: ICL-24-ABSSSI2
First Posted: November 18, 2015    Key Record Dates
Results First Posted: July 11, 2018
Last Update Posted: August 7, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Soft Tissue Infections
Anti-Bacterial Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action