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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

613

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2015

Geographic Reach

10 countries

54 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

November 1, 2015

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2017

Completed

11 months until next milestone

Results Posted

Study results publicly available

July 11, 2018

Completed

Last Updated

August 7, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

November 13, 2015

Results QC Date

June 14, 2018

Last Update Submit

July 10, 2018

Conditions

Skin Structures and Soft Tissue Infections

Outcome Measures

Primary Outcomes (1)

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).
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
7 to14 days after the end of treatment

Study Arms (2)

iclaprim

EXPERIMENTAL

iclaprim 80 mg intravenous every 12 hours

Drug: Iclaprim

vancomycin

ACTIVE COMPARATOR

vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance

Drug: Vancomycin

Interventions

IclaprimDRUG

Experimental treatment

Also known as: MTF-100

iclaprim

VancomycinDRUG

Active comparator

Also known as: Vancocin

vancomycin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Motif Biolead

Study Sites (54)

California

Anaheim, California, 92804, United States

Location

California

Buena Park, California, 90620, United States

Location

California

Chula Vista, California, 91911, United States

Location

California

La Palma, California, 90623, United States

Location

California

Long Beach, California, 90813, United States

Location

St. Mary Medical Center ER

Long Beach, California, 90813, United States

Location

Florida

Hollywood, Florida, 33021, United States

Location

Florida

Miami, Florida, 33130-2433, United States

Location

Florida

Miami, Florida, 33130, United States

Location

Georgia

Columbus, Georgia, 31904, United States

Location

Montana

Butte, Montana, 59701, United States

Location

Nevada

Las Vegas, Nevada, 89109, United States

Location

New Jersey

Somers Point, New Jersey, 08244, United States

Location

Ohio

Lima, Ohio, 45801, United States

Location

Tennessee

Smyrna, Tennessee, 37167-6826, United States

Location

Washington

Kennewick, Washington, 99336, United States

Location

Washington

Richland, Washington, 99352, United States

Location

Argentina

Buenos Aires, C1425DQK, Argentina

Location

Argentina

Buenos Aires, C1430BKC, Argentina

Location

Belgium

Brussels, 1000, Belgium

Location

Belgium

Brussels, 1070, Belgium

Location

Croatia

Slavonski Brod, 35000, Croatia

Location

Croatia

Zadar, 23000, Croatia

Location

Croatia

Zagreb, 10000, Croatia

Location

Czech Republic

Hradec Králové, 500 05, Czechia

Location

Czech Republic

Ostrava, 70852, Czechia

Location

Czech Republic

Příbram, 261 01, Czechia

Location

Czech Republic

Ústí nad Labem, 400 11, Czechia

Location

Estonia

Kohtla-Järve, 31025, Estonia

Location

Estonia

Tallinn, 13419, Estonia

Location

Estonia

Tallinn, 31419, Estonia

Location

Estonia

Tartu, 51014, Estonia

Location

Estonia

Võru, 65526, Estonia

Location

Hungary

Budapest, 1085, Hungary

Location

Hungary

Miskolc, 3529, Hungary

Location

Hungary

Szeged, 6720, Hungary

Location

Hungary

Székesfehérvár, 8000, Hungary

Location

Hungary

Veszprém, 8200, Hungary

Location

Portugal

Amadora, 2720-276, Portugal

Location

Portugal

Braga, 4710-243, Portugal

Location

Portugal

Porto, 4200-319, Portugal

Location

Portugal

Santarém, 2005-177, Portugal

Location

Portugal

Viana do Castelo, 4901-858, Portugal

Location

Romania

Arad, 310037, Romania

Location

Romania

Bucharest, 20475, Romania

Location

Romania

Bucharest, 41914, Romania

Location

Romania

Bucharest, 42122, Romania

Location

Romania

Bucharest, 50098, Romania

Location

Romania

Cluj-Napoca, 400162, Romania

Location

Romania

Craiova, 200642, Romania

Location

Romania

Timișoara, 300736, Romania

Location

Turkey

Aydin, 9100, Turkey (Türkiye)

Location

Turkey

Istanbul, 34098, Turkey (Türkiye)

Location

Turkey

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (2)

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.
PMID: 29783024DERIVED
Holland 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.
PMID: 29530858DERIVED

MeSH Terms

Conditions

Soft Tissue Infections

Interventions

iclaprimVancomycin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Stephanie Noviello
Organization: Motif BioSciences

Study Officials

Stephanie Noviello, MD
Motif Biosciences
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 18, 2015

Study Start

November 1, 2015

Primary Completion

August 8, 2017

Study Completion

August 8, 2017

Last Updated

August 7, 2018

Results First Posted

July 11, 2018

Record last verified: 2018-06

Locations

AR(2)RO(8)TU(3)CZ(4)BE(2)PT(5)ES(5)HU(5)US(17)CR(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

iclaprim

vancomycin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (54)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations