Skin Structures and Soft Tissue InfectionsPhase 3REVIVE-2NCT02607618
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
A Phase 3 study testing Iclaprim and Vancomycin in people with Skin Structures and Soft Tissue Infections, run by Motif Bio at 54 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
- 613 participants
- Where
- 54 sitesin 10 countries
- Study dates
- Nov 2015to 8 Aug 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
54 sites in 10 countries.
54 sites in 10 countries
United States17 sites
California
Anaheim, California, 92804
California
Buena Park, California, 90620
Montana
Butte, Montana, 59701
California
Chula Vista, California, 91911
Georgia
Columbus, Georgia, 31904
Florida
Hollywood, Florida, 33021
Washington
Kennewick, Washington, 99336
California
La Palma, California, 90623
Nevada
Las Vegas, Nevada, 89109
Ohio
Lima, Ohio, 45801
California
Long Beach, California, 90813
St. Mary Medical Center ER
Long Beach, California, 90813
Florida
Miami, Florida, 33130-2433
Florida
Miami, Florida, 33130
Washington
Richland, Washington, 99352
Tennessee
Smyrna, Tennessee, 37167-6826
New Jersey
Somers Point, New Jersey, 08244
Romania8 sites
Romania
Arad, 310037
Romania
Bucharest, 20475
Romania
Bucharest, 41914
Romania
Bucharest, 42122
Romania
Bucharest, 50098
Romania
Cluj-Napoca, 400162
Romania
Craiova, 200642
Romania
Timișoara, 300736
Estonia5 sites
Estonia
Kohtla-Järve, 31025
Estonia
Tallinn, 13419
Estonia
Tallinn, 31419
Estonia
Tartu, 51014
Estonia
Võru, 65526
Hungary5 sites
Hungary
Budapest, 1085
Hungary
Miskolc, 3529
Hungary
Szeged, 6720
Hungary
Székesfehérvár, 8000
Hungary
Veszprém, 8200
Portugal5 sites
Portugal
Amadora, 2720-276
Portugal
Braga, 4710-243
Portugal
Porto, 4200-319
Portugal
Santarém, 2005-177
Portugal
Viana do Castelo, 4901-858
Czechia4 sites
Czech Republic
Hradec Králové, 500 05
Czech Republic
Ostrava, 70852
Czech Republic
Příbram, 261 01
Czech Republic
Ústí nad Labem, 400 11
Croatia3 sites
Croatia
Slavonski Brod, 35000
Croatia
Zadar, 23000
Croatia
Zagreb, 10000
Turkey (Türkiye)3 sites
Turkey
Aydin, 9100
Turkey
Istanbul, 34098
Turkey
Trabzon, 61080
Argentina2 sites
Argentina
Buenos Aires, C1425DQK
Argentina
Buenos Aires, C1430BKC
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-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.
Read the 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).
- 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.
Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
≥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 to 72 hours after first dose of study drug
Secondary outcomes (1)
Number of Participants With 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 posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion8 Aug 2017
- Study completion8 Aug 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
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motif Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Noviello, MD, Study director, Motif Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607618
- Sponsor's protocol ID
- ICL-24-ABSSSI2
- Acronym
- REVIVE-2
- Status last verified
- Jun 2018
- First submitted
- 13 Nov 2015
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 29783024Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May.
PubMed 29530858
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 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-2
- ClinicalTrials.gov ID
- NCT02607618
- Acronym / sponsor ID
- REVIVE-2 / ICL-24-ABSSSI2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Motif BioIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Posted 11 Jul 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 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 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
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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 29530858Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May.
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.
Stephanie Noviello, MD study director
Motif Biosciences
54 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 54 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Romania, Estonia, Hungary, Portugal 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 11 Jul 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?
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). 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 NCT02607618, 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 7 Aug 2018.