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

July 10, 2018 updated by: Motif Bio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

613

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1430BKC
        • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425DQK
        • Argentina
  • Belgium
      • Brussels, Belgium, 1000
        • Belgium
      • Brussels, Belgium, 1070
        • Belgium
  • Croatia
      • Slavonski Brod, Croatia, 35000
        • Croatia
      • Zadar, Croatia, 23000
        • Croatia
      • Zagreb, Croatia, 10000
        • Croatia
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Czech Republic
      • Ostrava, Czechia, 70852
        • Czech Republic
      • Pribram, Czechia, 261 01
        • Czech Republic
      • Usti nad Labem, Czechia, 400 11
        • Czech Republic
  • Estonia
      • Kohtla-Jarve, Estonia, 31025
        • Estonia
      • Tallinn, Estonia, 13419
        • Estonia
      • Tallinn, Estonia, 31419
        • Estonia
      • Tartu, Estonia, 51014
        • Estonia
      • Voru, Estonia, 65526
        • Estonia
  • Hungary
      • Budapest, Hungary, 1085
        • Hungary
      • Miskolc, Hungary, 3529
        • Hungary
      • Szeged, Hungary, 6720
        • Hungary
      • Szekesfehervar, Hungary, 8000
        • Hungary
      • Veszprem, Hungary, 8200
        • Hungary
  • Portugal
      • Amadora, Portugal, 2720-276
        • Portugal
      • Braga, Portugal, 4710-243
        • Portugal
      • Porto, Portugal, 4200-319
        • Portugal
      • Santarem, Portugal, 2005-177
        • Portugal
      • Viana do Castelo, Portugal, 4901-858
        • Portugal
  • Romania
      • Arad, Romania, 310037
        • Romania
      • Bucharest, Romania, 20475
        • Romania
      • Bucharest, Romania, 41914
        • Romania
      • Bucuresti, Romania, 42122
        • Romania
      • Bucuresti, Romania, 50098
        • Romania
      • Cluj-Napoca, Romania, 400162
        • Romania
      • Craiova, Romania, 200642
        • Romania
      • Timisoara, Romania, 300736
        • Romania
  • Turkey
      • Aydin, Turkey, 9100
        • Turkey
      • Istanbul, Turkey, 34098
        • Turkey
      • Trabzon, Turkey, 61080
        • Turkey
  • United States
    • California
      • Anaheim, California, United States, 92804
        • California
      • Buena Park, California, United States, 90620
        • California
      • Chula Vista, California, United States, 91911
        • California
      • La Palma, California, United States, 90623
        • California
      • Long Beach, California, United States, 90813
        • California
      • Long Beach, California, United States, 90813
        • St. Mary Medical Center ER
    • Florida
      • Hollywood, Florida, United States, 33021
        • Florida
      • Miami, Florida, United States, 33130-2433
        • Florida
      • Miami, Florida, United States, 33130
        • Florida
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Georgia
    • Montana
      • Butte, Montana, United States, 59701
        • Montana
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • New Jersey
    • Ohio
      • Lima, Ohio, United States, 45801
        • Ohio
    • Tennessee
      • Smyrna, Tennessee, United States, 37167-6826
        • Tennessee
    • Washington
      • Kennewick, Washington, United States, 99336
        • Washington
      • Richland, Washington, United States, 99352
        • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iclaprim
iclaprim 80 mg intravenous every 12 hours
Drug: Iclaprim
Experimental treatment
Other Names:
  • 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 Names:
  • Vancocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 48 to 72 hours after first dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 to14 days after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Motif Bio

Investigators

  • Study Director: Stephanie Noviello, MD, Motif Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 8, 2017

Study Completion (Actual)

August 8, 2017

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICL-24-ABSSSI2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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