Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
Information source: Rib-X Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infectious Skin Diseases; Bacterial Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Abscess
Intervention: RX-1741 (Drug); RX-1741 (Drug); linezolid (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Rib-X Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Scott Hopkins, MD, Study Director, Affiliation: Rib-X Pharmaceuticals, Inc.
Summary
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
Clinical Details
Official title: A Phase 2, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety and Efficacy of RX-1741 Versus Linezolid in the Outpatient Treatment of Adult Patients With Uncomplicated Skin and Skin Structure Infection
Study design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: clinical evidence of cure
Secondary outcome: evaluation of safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative
wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis,
acute paroncyhia or a deep tissue abscess such as pilonodal 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
- Patient residing in a chronic care facility
- Any underlying condition or disease state that would interfere with the completion of
the study procedures and evaluation of the absorption of study drug
Locations and Contacts
Drug Research & Analysis Corp, Montgomery, Alabama, United States
Olive View- UCLA Center, Dept. Emergency Medicine, Sylmar, California, United States
HealthCare Partners Medical Group, Pasadena, California, United States
OWENS Pharma Research Center, Long Beach, California, United States
Healthcare Partners Medical Group, Los Angeles, 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
Additional Information
Starting date: December 2007
Last updated: May 2, 2008
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