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| Sponsor: | Rib-X Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Rib-X Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00719810 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Structure Infections Bacterial Skin Diseases Staphylococcal Skin Infections |
Drug: delafloxacin Drug: tigecycline |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 150 |
| Study Start Date: | June 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: delafloxacin
300 mg intravenous every 12 hours
|
| Experimental: 2 |
Drug: delafloxacin
450 mg intravenous every 12 hours
|
| Active Comparator: 3 |
Drug: tigecycline
100 mg then 50 mg intravenous tigecycline every 12 hours
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| 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 | |
| United States, Florida | |
| Internal Medicine Associates of Lee County | |
| Fort Myers, Florida, United States | |
| United States, Georgia | |
| 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 | |
| United States, Montana | |
| St. James Health Care | |
| Butte, Montana, United States | |
| United States, Ohio | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States | |
| United States, Texas | |
| Westbury Medical Clinic | |
| Houston, Texas, United States | |
| West Houston Clinical Research Services | |
| Houston, Texas, United States | |
| Puerto Rico | |
| Clinical Research Puerto Rico, Inc | |
| San Juan, Puerto Rico | |
| Study Director: | Jeanne Breen, MD | Rib-X Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Jeanne Breen, MD, Rib-X Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00719810 History of Changes |
| Other Study ID Numbers: | RX-3341-201 |
| Study First Received: | July 18, 2008 |
| Results First Received: | January 7, 2010 |
| Last Updated: | April 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
complicated skin |
|
Skin Diseases Skin Diseases, Infectious Staphylococcal Skin Infections Skin Diseases, Bacterial Infection Staphylococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Tigecycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |