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

Staphylococcal Skin Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719810
• Other study ID #: RX-3341-201
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2008
• Last updated: June 30, 2014
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: June 2014
• Source: Melinta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bacterial Skin Diseases
• Communicable Diseases
• Infection
• Skin Diseases
• Skin Diseases, Bacterial
• Skin Diseases, Infectious
• Skin Structure Infections
• Staphylococcal Skin Infections

Intervention

Drug:
• delafloxacin
300 mg intravenous every 12 hours
• delafloxacin
450 mg intravenous every 12 hours
• tigecycline
100 mg then 50 mg intravenous tigecycline every 12 hours

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Melinta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No