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

Melinta Therapeutics

Status and phase

Completed

Phase 2

Conditions

Bacterial Skin Diseases

Staphylococcal Skin Infections

Skin Structure Infections

Treatments

Drug: tigecycline

Drug: delafloxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00719810

RX-3341-201

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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