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Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

This study has been completed.
Sponsor:
Information provided by:
Rib-X Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00719810
First received: July 18, 2008
Last updated: April 20, 2011
Last verified: April 2011
History of Changes

July 18, 2008
April 20, 2011
June 2008
October 2008   (final data collection date for primary outcome measure)
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 14-21 days after the last dose of study drug ] [ Designated as safety issue: No ]
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
clinical response at TOC (test of cure) [ Time Frame: 2-3 weeks after the final dose of study drug ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00719810 on ClinicalTrials.gov Archive Site
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) [ Time Frame: 14-21 days after the last dose of study drug ] [ Designated as safety issue: No ]
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
  • evaluate clinical efficacy of delafloxacin in patients with cSSSIs caused by methicillin-resistant Staphylococcus aureus (MRSA) [ Time Frame: 2-3 weeks after the final dose of study drug ] [ Designated as safety issue: No ]
  • evaluate microbiologic efficacy of delafloxacin [ Time Frame: 2-3 weeks after the final dose of study drug ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Skin Structure Infections
  • Bacterial Skin Diseases
  • Staphylococcal Skin Infections
  • Drug: delafloxacin
    300 mg intravenous every 12 hours
  • Drug: delafloxacin
    450 mg intravenous every 12 hours
  • Drug: tigecycline
    100 mg then 50 mg intravenous tigecycline every 12 hours
  • Experimental: 1
    Intervention: Drug: delafloxacin
  • Experimental: 2
    Intervention: Drug: delafloxacin
  • Active Comparator: 3
    Intervention: Drug: tigecycline
Not Provided

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

Inclusion Criteria:

  • Adult (≥18 years of age) men or women with cSSSI
  • Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment
  • Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug
  • The patient must be willing to comply with protocol requirements

Exclusion Criteria:

  • Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives
  • Chronic or underlying skin condition at the site of infection
  • Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
  • An infection that would normally have a high cure rate after surgical incision alone
  • Any infection expected to require other antimicrobial agents in addition to study drug
  • Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment
  • A severely compromised immune system
  • History of Child-Pugh Class B or C liver disease or severe renal impairment (creatinine clearance of <30 mL/minute)
  • Pregnancy or lactation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00719810
RX-3341-201
No
Jeanne Breen, MD, Rib-X Pharmaceuticals, Inc.
Rib-X Pharmaceuticals, Inc.
Not Provided
Study Director: Jeanne Breen, MD Rib-X Pharmaceuticals, Inc.
Rib-X Pharmaceuticals, Inc.
April 2011

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