MedTrace Logo

Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

NCT02570490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 716

Last updated 2019-04-19

No results posted yet for this study

Summary

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI

Conditions

  • Acute Bacterial Skin and Skin Structure Infections

Interventions

DRUG

sodium fusidate

DRUG

linezolid

Sponsors & Collaborators

  • Arrevus Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Pushkin, MD · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

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 NCT02570490 on ClinicalTrials.gov