Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
NCT ID: NCT00719810
Last Updated: 2014-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2008-06-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
delafloxacin
300 mg intravenous every 12 hours
2
delafloxacin
450 mg intravenous every 12 hours
3
tigecycline
100 mg then 50 mg intravenous tigecycline every 12 hours
Interventions
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delafloxacin
300 mg intravenous every 12 hours
delafloxacin
450 mg intravenous every 12 hours
tigecycline
100 mg then 50 mg intravenous tigecycline every 12 hours
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Melinta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeanne Breen, MD
Role: STUDY_DIRECTOR
Melinta Therapeutics, Inc.
Locations
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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
Clinical Research Puerto Rico, Inc
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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RX-3341-201
Identifier Type: -
Identifier Source: org_study_id
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