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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670215
• Other study ID #: 100588
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2008
• Last updated: December 18, 2014
• Start date: April 2004
• Est. completion date: October 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Ciprofloxacin single dose
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.
• Ciprofloxacin triple dose
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Italy,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriological Response (bacteriuria vs. no bacteriuria)		10-14 days after last dose of study med	No
Secondary	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.	No
Secondary	Incidence of post-procedure GU tract infections other than bacteriuria		any time after the TRNBP	No

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