Clinical trial NCT00670215: BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Keywords: Prevention of infectious complications
transrectal needle biopsies of the prostate
TRNBP
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 497
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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)

Primary outcomes:
measure: Bacteriological Response (bacteriuria vs. no bacteriuria)
timeFrame: 10-14 days after last dose of study med
Secondary outcomes:
measure: Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)
timeFrame: 10-14 days after last dose of study med.
measure: Incidence of post-procedure GU tract infections other than bacteriuria
timeFrame: any time after the TRNBP
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Ocala
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Hopedale
country: United States
state: Massachusetts
city: New Brunswick
country: United States
state: New Jersey
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Simpsonville
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Salvador
country: Brazil
state: Bahia
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Porto Alegre
country: Brazil
state: RS
city: Rio de Janeiro
country: Brazil
city: São Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Fleurimont
country: Canada
state: Quebec
city: Laval
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Bergamo
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Zapopan
country: Mexico
state: Jalisco
city: Villahermosa
country: Mexico
state: Tabasco
city: Monterrey
country: Mexico
city: México D.F.
country: Mexico
city: México, D. F.
country: Mexico
city: México, D.F.
country: Mexico
city: Vigo
country: Spain
state: Pontevedra
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: