Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

Original Study ID : RX-1741-202

NCT ID : NCT00646958

Brief Title : Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

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

Brief 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

Source : Rib-X Pharmaceuticals, Inc.

Overall Status : Completed

Start Date : December 2007

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Parallel Assignment

Enrollment : 150

Verification Date : May 2008

First Received Date : March 26, 2008

Trial Eligibility

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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Drug Research & Analysis Corp

City : Montgomery

State : Alabama

Country : United States

Facility Name : Olive View- UCLA Center, Dept. Emergency Medicine

City : Sylmar

State : California

Country : United States

Facility Name : HealthCare Partners Medical Group

City : Pasadena

State : California

Country : United States

Facility Name : OWENS Pharma Research Center

City : Long Beach

State : California

Country : United States

Facility Name : Healthcare Partners Medical Group

City : Los Angeles

State : California

Country : United States

Facility Name : South Florida Clinical Research

City : Atlantis

State : Florida

Country : United States

Facility Name : Southeast Regional Research Group

City : Columbus

State : Georgia

Country : United States

Facility Name : Contemporary Medicine, LLC

City : Hinesville

State : Georgia

Country : United States

Facility Name : Infectious Disease of Indiana, PSC.

City : Indianapolis

State : Indiana

Country : United States

Facility Name : Clinical Trials of America, Inc.

City : Shreveport

State : Louisiana

Country : United States

Facility Name : Arnold Markowitz, MD., PC

City : Keego Harbor

State : Michigan

Country : United States

Facility Name : Mercury Street Medical Group, LLC

City : Butte

State : Montana

Country : United States

Facility Name : Jamaica Hospital Medical Center

City : Jamaica

State : New York

Country : United States

Facility Name : ALL-TRIALS Clinical Research, LLC

City : Winston-Salem

State : North Carolina

Country : United States

Facility Name : Summa Health System

City : Akron

State : Ohio

Country : United States

Facility Name : Brandywine Clinical Research

City : Downington

State : Pennsylvania

Country : United States

Facility Name : Warminster Medical Associates, P.C.

City : Warminster

State : Pennsylvania

Country : United States

Facility Name : McKenzie Medical Center

City : McKenzie

State : Tennessee

Country : United States

Facility Name : J. Lewis Research, Inc.

City : Salt Lake City

State : Utah

Country : United States

Clinical Trial Name -Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections