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

Phase 2

Completed

• Conditions: Skin Structure Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections
• Interventions: Drug: delafloxacin; Drug: tigecycline

• Registration Number: NCT00719810
• Lead Sponsor: Melinta Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2010-01-07
• Results First Submitted QC: 2010-01-07
• Results First Posted: 2010-02-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	delafloxacin	-
3	tigecycline	-
1	delafloxacin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population	14-21 days after the last dose of study drug	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

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

Trial Locations

Locations (12)

Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

Physician Alliance Research Center; 🇺🇸 Anaheim, California, United States

Tri City Medical Center; 🇺🇸 Oceanside, California, United States

Crest Clinical Trials; 🇺🇸 Santa Ana, California, United States

Internal Medicine Associates of Lee County; 🇺🇸 Fort Myers, Florida, United States

Joseph M. Still Research Foundation, Inc.; 🇺🇸 Augusta, Georgia, United States

Southeast Regional Research Group; 🇺🇸 Savannah, Georgia, United States

St. James Health Care; 🇺🇸 Butte, Montana, United States

Clinical Research Puerto Rico, Inc; 🇵🇷 San Juan, Puerto Rico

West Houston Clinical Research Services; 🇺🇸 Houston, Texas, United States

Westbury Medical Clinic; 🇺🇸 Houston, Texas, United States

Quality of Life Medical Center, LLC; 🇺🇸 Hawaiian Gardens, California, United States