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.

Study Overview

• Status: Completed
• Conditions: Staphylococcal Skin Infections; Bacterial Skin Diseases; Skin Structure Infections
• Intervention / Treatment: Drug: delafloxacin; Drug: delafloxacin; Drug: tigecycline

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: delafloxacin; 300 mg intravenous every 12 hours; Drug: delafloxacin; 450 mg intravenous every 12 hours
Experimental: 2	Drug: delafloxacin; 300 mg intravenous every 12 hours; Drug: delafloxacin; 450 mg intravenous every 12 hours
Active Comparator: 3	Drug: tigecycline; 100 mg then 50 mg intravenous tigecycline every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population	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.	14-21 days after the last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)	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.	14-21 days after the last dose of study drug

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, Inc.
• Investigators: Study Director: Jeanne Breen, MD, Melinta Therapeutics, Inc.

Publications and helpful links

General Publications

• O'Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: June 30, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: skin; complicated
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Disease Attributes; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Suppuration; Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Skin Diseases; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tigecycline; Fluoroquinolones
• Other Study ID Numbers: RX-3341-201