Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melinta Therapeutics, Inc.
• Treatments: Linezolid; Oxazolidinones; Radezolid

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 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

• 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