Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

Completed · Phase 2

Conditions studied: Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Streptococcal Infections, Abscess

In brief

The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections

Key facts

Study ID: NCT00646958
Run by: Melinta Therapeutics, Inc.
People needed: 150
Starts: 2007-12-01
Expected to finish: 2008-04-01
Last updated by the study team: 2014-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients with uSSSI
Adult (men and women) ≥18 years
Females must be post-menopausal for at least 1 year or surgically sterile
Sexually active males must use a barrier method of birth control during and for 30 days after the study
Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis
The infection is accompanied by 2 or more of the following local signs and symptoms: Pain/tenderness, Swelling, Erythema, Localized warmth, Purulent drainage/discharge, Induration, Regional lymph node swelling or tenderness, Extension of redness
A sample for microbiologic culture must be obtained from the primary infection site at the screening visit
The patient must require and be a suitable candidate for oral antibiotic therapy in the opinion of the Investigator and be able to swallow tablets or capsules intact
A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures

You may not qualify if…

Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also excluded are skin infections resulting from animal bites
Patients with a complicated skin and skin structure infection as judged by the Investigator
Infections that can be treated by surgical incision alone according to the judgment of the Investigator
Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days
Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug
Concomitant topical therapy at the infection site for the period within 48 hours prior to study drug administration through TOC
A chronic or underlying skin condition at the site of infection or infections involving prosthetic materials
A wound secondary to burn injury or acne vulgaris
Any infection site that requires: intraoperative surgical debridement; excision of infected area
Documented or suspected bacteremia
Fungal infection involving the nail bed or scalp at the primary uSSSI site
Significant peripheral vascular disease
An abscess at an anatomical location where the incidence of anaerobic pathogen involvement is increased
Patient receiving a daily dose of > 15 mg of systemic prednisone or equivalent, for > 10 days within the period starting 14 days prior to study drug administration or anticipated through TOC
Patient with known human immunodeficiency virus (HIV) infection.
Medical history of hypersensitivity or allergic reaction to linezolid according to the judgment of the Investigator
Patients receiving serotonergic agents, selective serotonin reuptake inhibitors (SSRIs), or monoamine oxidase inhibitors (MAOIs)
Patients who have severe liver disease
History of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, carcinoid syndrome
Evidence of uncontrolled, clinically significant (according to the judgment of the Investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine disease; malignancy or psychiatric disorder
Current evidence of deep vein thrombosis or superficial thrombophlebitis
Experienced a recent clinically significant coagulopathy
Evidence of clinically significant immunosuppression
Patient who previously enrolled in this study
Patient who has previously enrolled in any other clinical trial within 4 weeks of enrollment through TOC. Treatment with an investigational drug within 4 weeks prior to study drug administration

Where it is running

Drug Research & Analysis Corp — Montgomery, Alabama, United States
OWENS Pharma Research Center — Long Beach, California, United States
Healthcare Partners Medical Group — Los Angeles, California, United States
HealthCare Partners Medical Group — Pasadena, California, United States
Olive View- UCLA Center, Dept. Emergency Medicine — Sylmar, California, United States
South Florida Clinical Research — Atlantis, Florida, United States
Southeast Regional Research Group — Columbus, Georgia, United States
Contemporary Medicine, LLC — Hinesville, Georgia, United States
Infectious Disease of Indiana, PSC. — Indianapolis, Indiana, United States
Clinical Trials of America, Inc. — Shreveport, Louisiana, United States
Arnold Markowitz, MD., PC — Keego Harbor, Michigan, United States
Mercury Street Medical Group, LLC — Butte, Montana, United States
Jamaica Hospital Medical Center — Jamaica, New York, United States
ALL-TRIALS Clinical Research, LLC — Winston-Salem, North Carolina, United States
Summa Health System — Akron, Ohio, United States
Brandywine Clinical Research — Downington, Pennsylvania, United States
Warminster Medical Associates, P.C. — Warminster, Pennsylvania, United States
McKenzie Medical Center — McKenzie, Tennessee, United States
J. Lewis Research, Inc. — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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