BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis

Completed · Phase 3 · Has a placebo group

Conditions studied: Bacterial Infections

In brief

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).

Key facts

Study ID

NCT00670215

Run by

Bayer

People needed

497

Starts

2004-04-01

Expected to finish

2004-10-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Sherman Oaks, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Ocala, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Hopedale, Massachusetts, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Simpsonville, South Carolina, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Spokane, Washington, United States
• Study site — Salvador, Estado de Bahia, Brazil
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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