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Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

NCT02600611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-06-19

Study results available
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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.

Conditions

  • Skin Structures and Soft Tissue Infections

Interventions

DRUG

iclaprim

Experimental treatment

DRUG

vancomycin

Active comparator

Sponsors & Collaborators

  • Motif Bio

    lead INDUSTRY

Principal Investigators

  • David Huang, MD, PhD · Motif BioSciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2017-01-30
Completion
2017-01-30

Countries

  • United States
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Latvia
  • Peru
  • Poland
  • Puerto Rico
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600611 on ClinicalTrials.gov