Status:
COMPLETED
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
Lead Sponsor:
Melinta Therapeutics, Inc.
Conditions:
Skin Structure Infections
Bacterial Skin Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00719810
Start Date
June 1 2008
End Date
October 1 2008
Last Update
July 14 2014
Active Locations (14)
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1
Physician Alliance Research Center
Anaheim, California, United States
2
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, United States
3
Tri City Medical Center
Oceanside, California, United States
4
Crest Clinical Trials
Santa Ana, California, United States