Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
Information source: Melinta Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Structure Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections
Intervention: delafloxacin (Drug); delafloxacin (Drug); tigecycline (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Melinta Therapeutics, Inc. Official(s) and/or principal investigator(s): Jeanne Breen, MD, Study Director, Affiliation: Melinta Therapeutics, Inc.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Secondary outcome: Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Clinical Research Puerto Rico, Inc, San Juan, Puerto Rico
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
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, Columbus, Georgia, United States
Southeast Regional Research Group, Ludowici, Georgia, United States
Southeast Regional Research Group, Savannah, Georgia, United States
St. James Health Care, Butte, Montana, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
West Houston Clinical Research Services, Houston, Texas, United States
Westbury Medical Clinic, Houston, Texas, United States
Additional Information
Starting date: June 2008
Last updated: June 30, 2014
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