Clinical trial NCT00646958: Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infectious Skin Diseases
Bacterial Skin Diseases
Staphylococcal Skin Infections
Streptococcal Infections
Abscess
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With a Clinical Response of Cure
timeFrame: Test of Cure (TOC), day 10-20
Secondary outcomes:
measure: Number of Patients With Per-Patient Microbiologic Response of Eradicated
timeFrame: Test of Cure (TOC), day 10-20
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Drug Research & Analysis Corp
state: Alabama
city: Long Beach
country: United States
facility: OWENS Pharma Research Center
state: California
city: Los Angeles
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Pasadena
country: United States
facility: HealthCare Partners Medical Group
state: California
city: Sylmar
country: United States
facility: Olive View- UCLA Center, Dept. Emergency Medicine
state: California
city: Atlantis
country: United States
facility: South Florida Clinical Research
state: Florida
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Hinesville
country: United States
facility: Contemporary Medicine, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Infectious Disease of Indiana, PSC.
state: Indiana
city: Shreveport
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Keego Harbor
country: United States
facility: Arnold Markowitz, MD., PC
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical Group, LLC
state: Montana
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Winston-Salem
country: United States
facility: ALL-TRIALS Clinical Research, LLC
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Downington
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Warminster
country: United States
facility: Warminster Medical Associates, P.C.
state: Pennsylvania
city: McKenzie
country: United States
facility: McKenzie Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Scott Hopkins, MD
role: STUDY_DIRECTOR
References: