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

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ClinicalTrials.gov Identifier: NCT02600611
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : March 22, 2017
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).

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
U.S. FDA Resources

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 (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). [ Time Frame: 48 to 72 hours after first dose of study drug ]

Secondary Outcome Measures :
  1. Resolution or near resolution of lesion at Test of Cure (TOC) visit [ Time Frame: 7 to14 days after the end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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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Sponsors and Collaborators
Motif Bio
Investigators
Study Director: David Huang, MD, PhD Motif BioSciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Last Update Posted: March 22, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Soft Tissue Infections
Infection
Vancomycin
Iclaprim
Anti-Bacterial Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action