Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

Phase 2

Completed

• Conditions: Infectious Skin Diseases; Bacterial Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Abscess
• Interventions: Drug: Radezolid; Drug: Linezolid

• Registration Number: NCT00646958
• Lead Sponsor: Melinta Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-03-24
• Results First Submitted QC: 2009-06-25
• Results First Posted: 2009-06-26
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Radezolid	Radezolid 450 mg PO BID
1	Radezolid	Radezolid 450 mg PO QD
3	Linezolid	Linezolid 600 mg PO BID

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Clinical Response of Cure	Test of Cure (TOC), day 10-20	To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Per-Patient Microbiologic Response of Eradicated	Test of Cure (TOC), day 10-20	The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.

Trial Locations

Locations (19)

Jamaica Hospital Medical Center; 🇺🇸 Jamaica, New York, United States

Mercury Street Medical Group, LLC; 🇺🇸 Butte, Montana, United States

Healthcare Partners Medical Group; 🇺🇸 Los Angeles, California, United States

Southeast Regional Research Group; 🇺🇸 Columbus, Georgia, United States

HealthCare Partners Medical Group; 🇺🇸 Pasadena, California, United States

Contemporary Medicine, LLC; 🇺🇸 Hinesville, Georgia, United States

Arnold Markowitz, MD., PC; 🇺🇸 Keego Harbor, Michigan, United States

Olive View- UCLA Center, Dept. Emergency Medicine; 🇺🇸 Sylmar, California, United States

Brandywine Clinical Research; 🇺🇸 Downington, Pennsylvania, United States

Summa Health System; 🇺🇸 Akron, Ohio, United States

OWENS Pharma Research Center; 🇺🇸 Long Beach, California, United States

ALL-TRIALS Clinical Research, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Infectious Disease of Indiana, PSC.; 🇺🇸 Indianapolis, Indiana, United States

South Florida Clinical Research; 🇺🇸 Atlantis, Florida, United States

Drug Research & Analysis Corp; 🇺🇸 Montgomery, Alabama, United States

Clinical Trials of America, Inc.; 🇺🇸 Shreveport, Louisiana, United States

McKenzie Medical Center; 🇺🇸 McKenzie, Tennessee, United States

J. Lewis Research, Inc.; 🇺🇸 Salt Lake City, Utah, United States

Warminster Medical Associates, P.C.; 🇺🇸 Warminster, Pennsylvania, United States