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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
613

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Motif Bio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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