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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00481689 |
Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is safe and works to treat complicated urinary tract infections caused by Pseudomonas aeruginosa. The study doctor will also gather information about using Cipro XR to treat complicated urinary tract infections caused by other bacteria. About 500 people with complicated urinary tract infections who are 18 years old and older will join this study. Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has been shown to be safe and effective. This study is being done to gather more information on using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas aeruginosa, as well as by other bacteria.
Condition | Intervention | Phase |
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Urinary Tract Infections |
Drug: Cipro XR (Ciprofloxacin, BAYQ3939) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Open-Label, Noncomparative, Multicenter Study to Evaluate the Efficacy and Safety of Ciprofloxacin Extended Release (Cipro XR) 1000 mg Tablets Given Once Daily for 7 to 14 Days in the Treatment of Patients 18 Years or Older With Complicated Urinary Tract Infections Caused by Pseudomonas Aeruginosa and Other Common Uropathogens |
Estimated Enrollment: | 500 |
Study Start Date: | May 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have at last one of the underlying conditions
Patients must have one clean-catch, midstream urine culture or culture from catheter (obtained using sterile technique, not from a Foley bag) that was obtained within 48 hours of enrollment and had a positive results:
Exclusion Criteria:
Study ID Numbers: | 11490 |
Study First Received: | June 1, 2007 |
Last Updated: | June 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00481689 |
Health Authority: | United States: Food and Drug Administration |
Cipro Complicated UTI Pseudomonas aeruginosa |
Ciprofloxacin Urologic Diseases Urinary Tract Infections |
Anti-Infective Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Infection Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |