Abscess Clinical Trial
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
Verified date | February 2014 |
Source | Melinta Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Summa Health System | Akron | Ohio |
United States | South Florida Clinical Research | Atlantis | Florida |
United States | Mercury Street Medical Group, LLC | Butte | Montana |
United States | Southeast Regional Research Group | Columbus | Georgia |
United States | Brandywine Clinical Research | Downington | Pennsylvania |
United States | Contemporary Medicine, LLC | Hinesville | Georgia |
United States | Infectious Disease of Indiana, PSC. | Indianapolis | Indiana |
United States | Jamaica Hospital Medical Center | Jamaica | New York |
United States | Arnold Markowitz, MD., PC | Keego Harbor | Michigan |
United States | OWENS Pharma Research Center | Long Beach | California |
United States | Healthcare Partners Medical Group | Los Angeles | California |
United States | McKenzie Medical Center | McKenzie | Tennessee |
United States | Drug Research & Analysis Corp | Montgomery | Alabama |
United States | HealthCare Partners Medical Group | Pasadena | California |
United States | J. Lewis Research, Inc. | Salt Lake City | Utah |
United States | Clinical Trials of America, Inc. | Shreveport | Louisiana |
United States | Olive View- UCLA Center, Dept. Emergency Medicine | Sylmar | California |
United States | Warminster Medical Associates, P.C. | Warminster | Pennsylvania |
United States | ALL-TRIALS Clinical Research, LLC | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Melinta Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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