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Completed

NCT Number: NCT00761215

Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.

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Key information

Conditions

Skin Diseases, Infectious Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases Skin Diseases, Bacterial Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Trius Study Site #011, Dothan, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
  • Suspected or confirmed infection due to a gram-positive organism

Exclusion criteria

  • Complicated skin and skin structure infection due to gram-negative organisms
  • Complicated skin and skin structure infections requiring more than 7 days of therapy
  • Uncontrolled diabetes
  • Chronic systemic immunosuppressive therapy
  • AIDS with CD4 count < 200 cells/mm3
  • Uncontrolled hypertension
  • Mild moderate or severe renal failure
  • Severe hepatic disease
  • Neutropenia
  • Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
  • Women who are pregnant or nursing

Treatment and study plan

TR-701 200 mg

Drug

oral TR-701 200 mg for 5 to 7 days

TR-701 300 mg

Drug

oral TR-701 300 mg for 5 to 7 days

TR-701 400 mg

Drug

TR-701 400 mg for 5 to 7 days

Primary outcomes

  1. Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set

    Time frame: 7 to 14 days after the last dose of study drug

    Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

  2. Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set

    Time frame: 7-14 days after last dose of study drug

    Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Secondary outcomes

  1. Response Rate at End of Therapy

    Time frame: last day of study treatment

    Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

  2. Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set

    Time frame: 7-14 days after last dose of study drug

    Satisfactory microbiological outcomes are eradication and presumed eradication

  3. Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set

    Time frame: 21 to 28 days after the last study drug

    Persistent clinical cure was defined as continuing favorable response.

  4. To Evaluate the Safety Profile of Tedizolid Phosphate

    Time frame: Multiple

  5. Population PK

    Time frame: Multiple

  6. Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set

    Time frame: 21-28 days after last study drug

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 29, 2008
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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