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

600

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2015

Shorter than P25 for phase_3

Geographic Reach

10 countries

56 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

1.2 years study duration

Study Start

First participant enrolled

November 1, 2015

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

June 19, 2018

Completed

Last Updated

June 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

November 5, 2015

Results QC Date

March 20, 2018

Last Update Submit

May 19, 2018

Conditions

Skin Structures and Soft Tissue Infections

Outcome Measures

Primary Outcomes (1)

≥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).
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
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 (56)

California

Buena Park, California, 90620, United States

Location

California

La Mesa, California, 91942, United States

Location

California

Long Beach, California, 90806, United States

Location

California

Modesto, California, 95350-449, United States

Location

California

Oceanside, California, 92056, United States

Location

California

Torrance, California, 90503, United States

Location

District of Columbia

Washington D.C., District of Columbia, 20017, United States

Location

Florida

DeLand, Florida, 32770-0834, United States

Location

Florida

Miami, Florida, 33144, United States

Location

Indiana

Indianapolis, Indiana, 46260, United States

Location

Nebraska

Lincoln, Nebraska, 68510-2462, United States

Location

Tennessee

Franklin, Tennessee, 37067, United States

Location

Tennessee

Franklin, Tennessee, 37094, United States

Location

Texas

Channelview, Texas, 77530, United States

Location

Texas

McAllen, Texas, 78503, United States

Location

Washington

Seattle, Washington, 98195, United States

Location

Bulgaria

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Bulgaria

Sofia, 1527, Bulgaria

Location

Chile

Temuco, 4781151, Chile

Location

Colombia

Barranquilla, 80020, Colombia

Location

Germany

Cologne, Northwest, 50937, Germany

Location

Germany

Dessau, 6847, Germany

Location

Germany

Mainz, 55131, Germany

Location

Germany

Münster, 48149, Germany

Location

Latvia

Daugavpils, LV-5417, Latvia

Location

Latvia

Liepāja, LV3414, Latvia

Location

Latvia

Rēzekne, 4600, Latvia

Location

Latvia

Riga, LV-1002, Latvia

Location

Latvia

Riga, LV-1038, Latvia

Location

Peru

Cerro de Pasco, LIM, 1, Peru

Location

Peru

Cusco, Peru

Location

Peru

Ica, Peru

Location

Peru

La Libertad, Peru

Location

Peru

Lima, 01, Peru

Location

Peru

Lima, 29, Peru

Location

Peru

Lima, 31, Peru

Location

Peru

Piura, Peru

Location

Peru

San Borja, Peru

Location

Peru

San Juán de Miraflores, 29, Peru

Location

Poland

Bydgoszcz, 85-094, Poland

Location

Poland

Olsztyn, 10-229, Poland

Location

Poland

Warsaw, 00-909, Poland

Location

Poland

Wroclaw, 51-124, Poland

Location

Puerto Rico

Ponce, 780, Puerto Rico

Location

Puerto Rico

Río Grande, 745, Puerto Rico

Location

Ukraine

Cherkasy, 18009, Ukraine

Location

Ukraine

Ivano-Frankivsk, 76014, Ukraine

Location

Ukraine

Ivano-Frankivsk, 7608, Ukraine

Location

Ukraine

Kharkiv, 6100, Ukraine

Location

Ukraine

Kharkiv, 61037, Ukraine

Location

Ukraine

Kiev, 3110, Ukraine

Location

Ukraine

Odesa, 65025, Ukraine

Location

Ukraine

Odesa, 65082, Ukraine

Location

Ukraine

Zaporizhzhya, 69000, Ukraine

Location

Ukraine

Zaporizhzhya, 69032, Ukraine

Location

Ukraine

Zaporizhzhya, 69065, Ukraine

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
Huang 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.
PMID: 29281036DERIVED

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: David Huang
Organization: Motif BioSciences

Study Officials

David Huang, MD, PhD
Motif BioSciences
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
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 5, 2015

First Posted

November 9, 2015

Study Start

November 1, 2015

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

June 19, 2018

Results First Posted

June 19, 2018

Record last verified: 2018-04

Locations

UA(11)PL(4)CO(1)LA(5)PE(10)DE(4)US(16)BU(2)CL(1)PR(2)

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 (56)

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