Status:
COMPLETED
BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
Lead Sponsor:
Bayer
Conditions:
Bacterial Infections
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- Transrectal needle biopsy of the prostate required.
- A clean-catch midstream-urine (MSU) culture negative (\<104 CFU/mL) for possible pathogens at the Pre-Therapy Visit prior to the TRNBP.
- Gastrointestinal absorption is adequate as evidenced by passage of gas or feces per rectum and patient can tolerate oral food, fluids, and medication without vomiting or diarrhea.
Exclusion
- History of hypersensitivity to ciprofloxacin or other quinolone antibiotics
- Valvular heart disease that requires antibiotic prophylaxis to prevent bacterial endocarditis
- Concomitant use of theophylline, probenecid, or warfarin at any time during the entire study
- Renal insufficiency
- Known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
- Absolute neutrophil count (ANC) \<1000/mm3
- Human immunodeficiency virus (HIV) infection with a CD4 count \<200 cells/micL. HIV testing is NOT required
- Antibiotic administration within one week of the TRNBP
- Severe hepatic insufficiency (Child-Pugh C)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT00670215
Start Date
April 1 2004
End Date
October 1 2004
Last Update
December 19 2014
Active Locations (51)
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1
Birmingham, Alabama, United States, 35209
2
San Diego, California, United States, 92101
3
San Francisco, California, United States, 94117
4
Sherman Oaks, California, United States, 91403