Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00646958
First received: March 26, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Infectious Skin Diseases
Bacterial Skin Diseases
Staphylococcal Skin Infections
Streptococcal Infections
Abscess
Drug: Radezolid
Drug: Linezolid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Melinta Therapeutics, Inc.:

Primary Outcome Measures:
  • Number of Participants With a Clinical Response of Cure [ Time Frame: Test of Cure (TOC), day 10-20 ] [ Designated as safety issue: No ]
    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:
  • Number of Patients With Per-Patient Microbiologic Response of Eradicated [ Time Frame: Test of Cure (TOC), day 10-20 ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: December 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Radezolid 450 mg PO QD
Drug: Radezolid
450mg PO QD
Other Name: RX-1741
Experimental: 2
Radezolid 450 mg PO BID
Drug: Radezolid
450mg PO BID
Other Name: RX-1741
Active Comparator: 3
Linezolid 600 mg PO BID
Drug: Linezolid
600mg PO BID
Other Name: Zyvox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646958

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

No publications provided

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00646958     History of Changes
Other Study ID Numbers: RX-1741-202
Study First Received: March 26, 2008
Results First Received: March 24, 2009
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abscess
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Staphylococcal Skin Infections
Streptococcal Infections
Skin Diseases, Bacterial
Suppuration
Inflammation
Pathologic Processes
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Linezolid
Radezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 26, 2014