Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00646958
First received: March 26, 2008
Last updated: February 26, 2014
Last verified: February 2014

March 26, 2008
February 26, 2014
December 2007
April 2008   (final data collection date for primary outcome measure)
Number of Participants With a Clinical Response of Cure [ Time Frame: Test of Cure (TOC), day 10-20 ] [ Designated as safety issue: No ]
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.
clinical evidence of cure [ Time Frame: study day 5-20 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00646958 on ClinicalTrials.gov Archive Site
Number of Patients With Per-Patient Microbiologic Response of Eradicated [ Time Frame: Test of Cure (TOC), day 10-20 ] [ Designated as safety issue: No ]
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.
evaluation of safety and tolerability [ Time Frame: study day 1-20 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infectious Skin Diseases
  • Bacterial Skin Diseases
  • Staphylococcal Skin Infections
  • Streptococcal Infections
  • Abscess
  • Drug: Radezolid
    450mg PO QD
    Other Name: RX-1741
  • Drug: Radezolid
    450mg PO BID
    Other Name: RX-1741
  • Drug: Linezolid
    600mg PO BID
    Other Name: Zyvox
  • Experimental: 1
    Radezolid 450 mg PO QD
    Intervention: Drug: Radezolid
  • Experimental: 2
    Radezolid 450 mg PO BID
    Intervention: Drug: Radezolid
  • Active Comparator: 3
    Linezolid 600 mg PO BID
    Intervention: Drug: Linezolid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00646958
RX-1741-202
No
Melinta Therapeutics, Inc.
Melinta Therapeutics, Inc.
Not Provided
Study Director: Scott Hopkins, MD Melinta Therapeutics, Inc.
Melinta Therapeutics, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP