Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646958
• Other study ID #: RX-1741-202
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: February 26, 2014
• Start date: December 2007
• Est. completion date: April 2008

Study information

• 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

Clinical Trial 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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Bacterial Skin Diseases
• Communicable Diseases
• Infection
• Infectious Skin Diseases
• Skin Diseases
• Skin Diseases, Bacterial
• Skin Diseases, Infectious
• Staphylococcal Skin Infections
• Streptococcal Infections

Intervention

Drug:
• Radezolid
450mg PO QD
• Radezolid
450mg PO BID
• Linezolid
600mg PO BID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Melinta Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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