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Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

NCT00948142 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-04-19

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).

Conditions

  • Skin Diseases, Bacterial

Interventions

DRUG

CEM-102

600 mg BID oral tablets for 10-14 days

DRUG

Linezolid

600 mg BID oral tablets

DRUG

CEM-102

1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days

Sponsors & Collaborators

  • Arrevus Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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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 NCT00948142 on ClinicalTrials.gov