The primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (TRNBP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
497
Patients randomized to this regimen will receive a single-dose of ciprofloxacin MR 1000 mg PO approximately 2 to 3 hours prior to the TRNBP. Patients will also receive two doses of matching placebo approximately 24 hours prior to and approximately 24 hours after the TRNBP.
Patients randomized to this regimen will receive three doses of ciprofloxacin MR 1000 mg PO. The doses will be approximately 24 hours prior to the TRNBP, approximately 2 to 3 hours prior to the TRNBP, and approximately 24 hours after the TRNBP.
Bacteriological Response (bacteriuria vs. no bacteriuria)
Time frame: 10-14 days after last dose of study med
Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)
Time frame: 10-14 days after last dose of study med.
Incidence of post-procedure GU tract infections other than bacteriuria
Time frame: any time after the TRNBP
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Birmingham, Alabama, United States
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San Diego, California, United States
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San Francisco, California, United States
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Sherman Oaks, California, United States
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Waterbury, Connecticut, United States
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Ocala, Florida, United States
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Atlanta, Georgia, United States
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Roswell, Georgia, United States
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Chicago, Illinois, United States
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Hopedale, Massachusetts, United States
...and 41 more locations