Skin Structures and Soft Tissue InfectionsPhase 3REVIVE-1NCT02600611
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
A Phase 3 study testing iclaprim and vancomycin in people with Skin Structures and Soft Tissue Infections, run by Motif Bio at 56 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Structures and Soft Tissue Infections
- What is being tested?
- iclaprim and vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 56 sitesin 10 countries
- Study dates
- 1 Nov 2015to 30 Jan 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
56 sites in 10 countries.
56 sites in 10 countries
United States16 sites
California
Buena Park, California, 90620
Texas
Channelview, Texas, 77530
Florida
DeLand, Florida, 32770-0834
Tennessee
Franklin, Tennessee, 37067
Tennessee
Franklin, Tennessee, 37094
Indiana
Indianapolis, Indiana, 46260
California
La Mesa, California, 91942
Nebraska
Lincoln, Nebraska, 68510-2462
California
Long Beach, California, 90806
Texas
McAllen, Texas, 78503
Florida
Miami, Florida, 33144
California
Modesto, California, 95350-449
California
Oceanside, California, 92056
Washington
Seattle, Washington, 98195
California
Torrance, California, 90503
District of Columbia
Washington D.C., District of Columbia, 20017
Ukraine11 sites
Ukraine
Cherkasy, 18009
Ukraine
Ivano-Frankivsk, 76014
Ukraine
Ivano-Frankivsk, 7608
Ukraine
Kharkiv, 6100
Ukraine
Kharkiv, 61037
Ukraine
Kiev, 3110
Ukraine
Odesa, 65025
Ukraine
Odesa, 65082
Ukraine
Zaporizhzhya, 69000
Ukraine
Zaporizhzhya, 69032
Ukraine
Zaporizhzhya, 69065
Peru10 sites
Peru
Cerro de Pasco, LIM, 1
Peru
Cusco
Peru
Ica
Peru
La Libertad
Peru
Lima, 01
Peru
Lima, 29
Peru
Lima, 31
Peru
Piura
Peru
San Borja
Peru
San Juán de Miraflores, 29
Latvia5 sites
Latvia
Daugavpils, LV-5417
Latvia
Liepāja, LV3414
Latvia
Rēzekne, 4600
Latvia
Riga, LV-1002
Latvia
Riga, LV-1038
Germany4 sites
Germany
Cologne, Northwest, 50937
Germany
Dessau, 6847
Germany
Mainz, 55131
Germany
Münster, 48149
Poland4 sites
Poland
Bydgoszcz, 85-094
Poland
Olsztyn, 10-229
Poland
Warsaw, 00-909
Poland
Wroclaw, 51-124
About this study
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
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.
Read the 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).
- Being tested
- iclaprim, vancomycin
- Medical subject headings
- Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iclaprimDrug
Also called MTF-100
Experimental treatment
vancomycinDrug
Also called Vancocin
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| iclaprim | Experimental | iclaprim 80 mg intravenous every 12 hours Receives: Drug: iclaprim |
| vancomycin | Active comparator | vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance Receives: Drug: vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).
Measured: Baseline and 48-72 hours after first dose of study drug
Secondary outcomes (1)
Resolution or Near Resolution of Lesion at Test of Cure Visit
Resolution or near resolution of lesion at Test of Cure (TOC) visit
Measured: 7 to14 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start1 Nov 2015
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin Structures and Soft Tissue InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motif Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Huang, MD, PhD, Study director, Motif BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600611
- Sponsor's protocol ID
- ICL-23-ABSSSI1
- Acronym
- REVIVE-1
- Status last verified
- Apr 2018
- First submitted
- 5 Nov 2015
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19.
PubMed 29783024Huang DB, O'Riordan W, Overcash JS, Heller B, Amin F, File TM, Wilcox MH, Torres A, Dryden M, Holland TL, McLeroth P, Shukla R, Corey GR. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clin Infect Dis. 2018 Apr 3;66(8):1222-1229. doi: 10.1093/cid/cix987.
PubMed 29281036
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02600611
- Acronym / sponsor ID
- REVIVE-1 / ICL-23-ABSSSI1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Motif BioIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iclaprim | Experimental | Drug: iclaprimiclaprim 80 mg intravenous every 12 hours |
| vancomycin | Active comparator | Drug: vancomycinvancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iclaprimAlso: MTF-100Experimental treatment | Drug | iclaprim |
| vancomycinAlso: VancocinActive comparator | Drug | vancomycin |
Primary outcome
≥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).
1 secondary outcome
Resolution or Near Resolution of Lesion at Test of Cure Visit
Time frame: 7 to14 days after the end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29783024Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19.
- Derived from this study: PubMed 29281036Huang DB, O'Riordan W, Overcash JS, Heller B, Amin F, File TM, Wilcox MH, Torres A, Dryden M, Holland TL, McLeroth P, Shukla R, Corey GR. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clin Infect Dis. 2018 Apr 3;66(8):1222-1229. doi: 10.1093/cid/cix987.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Huang, MD, PhD study director
Motif BioSciences
56 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iclaprim and vancomycin in people with Skin Structures and Soft Tissue Infections, run by Motif Bio at 56 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Ukraine, Peru, Latvia, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.