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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days
Unnamed facility
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Scottsdale, Arizona, United States
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Cudahy, California, United States
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Fresno, California, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
...and 25 more locations
To evaluate safety and efficacy of ciprofloxacin XR for treatment of subjects with complicated urinary tract infections caused by P. aeruginosa and other urinary pathogens.
Time frame: 28-42 days after therapy
Clinical response
Time frame: TOC visit
Clinical response post- treatment
Time frame: 28-42 days after therapy
Adverse Event collection
Time frame: Until end of study
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