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Completed

NCT Number: NCT01519778

A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

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Key information

Conditions

Major Cutaneous Abscess Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Erysipelas Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Streptococcal Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Trius Investigator Site #118, Anaheim, California, United States

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About this study

This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients ≥ 18 years of age
  • Suspected or documented gram-positive infection from baseline Gram stain or culture.
  • Cellulitis/erysipelas or major cutaneous abscesses at Screening

Exclusion criteria

  • Postsurgical or open wound infections
  • Severe sepsis or septic shock
  • Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
  • Infections associated with, or in close proximity to, a prosthetic device
  • Known bacteremia or osteomyelitis at time of screening

Treatment and study plan

TR701 FA

Drug

1 tablet 200 mg once daily

Other names: Tedizolid

Primary outcomes

  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 24-31 days

    Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Bayer

Registry information

Official study title

Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2012
Registry last updated
Aug 29, 2018

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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