Clinical trial NCT00719810: Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Structure Infections
Bacterial Skin Diseases
Staphylococcal Skin Infections
Keywords: complicated
skin
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 complicated skin and skin structure infections.


Eligibility 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

Primary outcomes:
measure: Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
timeFrame: 14-21 days after the last dose of study drug
Secondary outcomes:
measure: Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
timeFrame: 14-21 days after the last dose of study drug
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Physician Alliance Research Center
state: California
city: Hawaiian Gardens
country: United States
facility: Quality of Life Medical Center, LLC
state: California
city: Oceanside
country: United States
facility: Tri City Medical Center
state: California
city: Santa Ana
country: United States
facility: Crest Clinical Trials
state: California
city: Fort Myers
country: United States
facility: Internal Medicine Associates of Lee County
state: Florida
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation, Inc.
state: Georgia
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Ludowici
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Butte
country: United States
facility: St. James Health Care
state: Montana
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
city: Houston
country: United States
facility: Westbury Medical Clinic
state: Texas
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Jeanne Breen, MD
role: STUDY_DIRECTOR
References:
citation: O'Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.