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 |
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Recruitment Status :
Completed
First Posted : November 9, 2015
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
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Sponsor:
Motif Bio
Information provided by (Responsible Party):
Motif Bio
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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 |
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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: iclaprim
iclaprim 80 mg intravenous every 12 hours
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Drug: iclaprim
Experimental treatment
Other Name: MTF-100 |
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Active Comparator: vancomycin
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
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Drug: vancomycin
Active comparator
Other Name: Vancocin |
Primary Outcome Measures :
- ≥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 :
- 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
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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:
- written informed consent;
- ≥18 years of age;
- a bacterial infection of the skin with a lesion size area of at least 75 cm2;
- a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
- the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).
Exclusion Criteria:
- severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
- infected diabetic foot ulcers;
- infected decubitus ulcers;
- necrotizing fasciitis or gangrene;
- uncomplicated skin or skin structure infection;
- infections associated with a prosthetic device;
- suspected or confirmed osteomyelitis;
- 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
Locations
Show 56 study locations
Sponsors and Collaborators
Motif Bio
Investigators
| Study Director: | David Huang, MD, PhD | Motif BioSciences |
Study Documents (Full-Text)
Documents provided by Motif Bio:
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):
| Responsible Party: | Motif Bio |
| ClinicalTrials.gov Identifier: | NCT02600611 |
| 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 Infections Vancomycin Iclaprim Anti-Bacterial Agents |
Anti-Infective Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |