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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00719810
First received: July 18, 2008
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Skin Structure Infections
Bacterial Skin Diseases
Staphylococcal Skin Infections
Drug: delafloxacin
Drug: tigecycline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Melinta Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: delafloxacin
300 mg intravenous every 12 hours
Experimental: 2 Drug: delafloxacin
450 mg intravenous every 12 hours
Active Comparator: 3 Drug: tigecycline
100 mg then 50 mg intravenous tigecycline every 12 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719810

Locations
United States, California
Physician Alliance Research Center
Anaheim, California, United States
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, United States
Tri City Medical Center
Oceanside, California, United States
Crest Clinical Trials
Santa Ana, California, United States
United States, Florida
Internal Medicine Associates of Lee County
Fort Myers, Florida, United States
United States, Georgia
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, United States
Southeast Regional Research Group
Columbus, Georgia, United States
Southeast Regional Research Group
Ludowici, Georgia, United States
Southeast Regional Research Group
Savannah, Georgia, United States
United States, Montana
St. James Health Care
Butte, Montana, United States
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States
United States, Texas
Westbury Medical Clinic
Houston, Texas, United States
West Houston Clinical Research Services
Houston, Texas, United States
Puerto Rico
Clinical Research Puerto Rico, Inc
San Juan, Puerto Rico
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Investigators
Study Director: Jeanne Breen, MD Melinta Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00719810     History of Changes
Other Study ID Numbers: RX-3341-201
Study First Received: July 18, 2008
Results First Received: January 7, 2010
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Melinta Therapeutics, Inc.:
complicated
skin

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Infectious
Staphylococcal Skin Infections
Skin Diseases, Bacterial
Infection
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Fluoroquinolones
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014