Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

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

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

Study Overview

• Status: Completed
• Conditions: Streptococcal Infections; Abscess; Staphylococcal Skin Infections; Infectious Skin Diseases; Bacterial Skin Diseases
• Intervention / Treatment: Drug: Radezolid; Drug: Radezolid; Drug: Linezolid

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Radezolid 450 mg PO QD	Drug: Radezolid; 450mg PO QD; Other Names: RX-1741; Drug: Radezolid; 450mg PO BID; Other Names: RX-1741
Experimental: 2; Radezolid 450 mg PO BID	Drug: Radezolid; 450mg PO QD; Other Names: RX-1741; Drug: Radezolid; 450mg PO BID; Other Names: RX-1741
Active Comparator: 3; Linezolid 600 mg PO BID	Drug: Linezolid; 600mg PO BID; Other Names: Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Clinical Response of Cure	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.	Test of Cure (TOC), day 10-20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Per-Patient Microbiologic Response of Eradicated	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.	Test of Cure (TOC), day 10-20

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, Inc.
• Investigators: Study Director: Scott Hopkins, MD, Melinta Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: March 26, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): March 31, 2008

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Disease Attributes; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Suppuration; Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Skin Diseases; Streptococcal Infections; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid; Oxazolidinones; Radezolid
• Other Study ID Numbers: RX-1741-202