Status:
COMPLETED
Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
Lead Sponsor:
Melinta Therapeutics, Inc.
Conditions:
Infectious Skin Diseases
Bacterial Skin Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 stru...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00646958
Start Date
December 1 2007
End Date
April 1 2008
Last Update
March 27 2014
Active Locations (19)
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1
Drug Research & Analysis Corp
Montgomery, Alabama, United States
2
OWENS Pharma Research Center
Long Beach, California, United States
3
Healthcare Partners Medical Group
Los Angeles, California, United States
4
HealthCare Partners Medical Group
Pasadena, California, United States