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
1 other identifier
interventional
150
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 26, 2009
CompletedMarch 27, 2014
February 1, 2014
4 months
March 26, 2008
March 24, 2009
February 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Patients With Per-Patient Microbiologic Response of Eradicated
Test of Cure (TOC), day 10-20
Study Arms (3)
1
EXPERIMENTALRadezolid 450 mg PO QD
2
EXPERIMENTALRadezolid 450 mg PO BID
3
ACTIVE COMPARATORLinezolid 600 mg PO BID
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Drug Research & Analysis Corp
Montgomery, Alabama, United States
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
South Florida Clinical Research
Atlantis, Florida, United States
Southeast Regional Research Group
Columbus, Georgia, United States
Contemporary Medicine, LLC
Hinesville, Georgia, United States
Infectious Disease of Indiana, PSC.
Indianapolis, Indiana, United States
Clinical Trials of America, Inc.
Shreveport, Louisiana, United States
Arnold Markowitz, MD., PC
Keego Harbor, Michigan, United States
Mercury Street Medical Group, LLC
Butte, Montana, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
ALL-TRIALS Clinical Research, LLC
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Brandywine Clinical Research
Downington, Pennsylvania, United States
Warminster Medical Associates, P.C.
Warminster, Pennsylvania, United States
McKenzie Medical Center
McKenzie, Tennessee, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This was an unblinded study, which raises the possibility of bias.
Results Point of Contact
- Title
- Eugene Sun, M.D.
- Organization
- Melinta Therapeutics
Study Officials
- STUDY DIRECTOR
Scott Hopkins, MD
Melinta Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
December 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
March 27, 2014
Results First Posted
June 26, 2009
Record last verified: 2014-02