Prospective, Randomized, Double-blind, Comparison of Ciprofloxacin Extended-release 1000 mg Tablets Given as Two Different Prophylactic Dosing Regimens (Regimen I - Single-dose Ciprofloxacin MR 1000 mg or Regimen II - Multiple-dose Ciprofloxacin MR 1000 mg Once Daily for 3 Days) for the Prevention of Post-operative Infectious Complications in Patients Undergoing Transrectal Needle Biopsy of the Prostate

Bayer0 sites497 target enrollmentApril 2004

ConditionsBacterial Infections

InterventionsCiprofloxacin single dose Ciprofloxacin triple dose

DrugsCiprofloxacin single dose Ciprofloxacin triple dose

Overview

Phase: Phase 3
Intervention: Ciprofloxacin single dose
Conditions: Bacterial Infections
Sponsor: Bayer
Enrollment: 497
Primary Endpoint: Bacteriological Response (bacteriuria vs. no bacteriuria)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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 regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (TRNBP).

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

October 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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)

Arms & Interventions

Arm 1

Intervention: Ciprofloxacin single dose

Arm 2

Intervention: Ciprofloxacin triple dose

Outcomes

Primary Outcomes

Bacteriological Response (bacteriuria vs. no bacteriuria)

Time Frame: 10-14 days after last dose of study med

Secondary Outcomes

Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)(10-14 days after last dose of study med.)
Incidence of post-procedure GU tract infections other than bacteriuria(any time after the TRNBP)