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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Skin Structure Infections, Bacterial Skin Diseases, Staphylococcal Skin Infections

Intervention / Treatment
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* Drug: delafloxacin
* Drug: delafloxacin
* Drug: tigecycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: delafloxacin<br>* 300 mg intravenous every 12 hours<br>|
| Experimental: 2<br> | Drug: delafloxacin<br>* 450 mg intravenous every 12 hours<br>|
| Active Comparator: 3<br> | Drug: tigecycline<br>* 100 mg then 50 mg intravenous tigecycline every 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complicated, skin