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TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

NCT01170221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2018-08-29

Study results available
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Summary

This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.

Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Conditions

  • Skin and Subcutaneous Tissue Bacterial Infections

Interventions

DRUG

TR-701 FA

Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.

DRUG

Linezolid

Oral Linezolid 600 mg twice daily for 10 days

Sponsors & Collaborators

  • Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Philippe G Prokocimer, MD · Trius Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-15
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Latvia
  • Peru
  • Slovakia
  • Ukraine

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 NCT01170221 on ClinicalTrials.gov