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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00670215

Collaborator

(none)

497

Enrollment

Locations

Arms

Duration (Months)

9.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Drug: Ciprofloxacin single dose Drug: Ciprofloxacin triple dose	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

497 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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 Start Date :

Apr 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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.
Experimental: Arm 2	Drug: 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.

Arm

Intervention/Treatment

Experimental: Arm 1

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.

Experimental: Arm 2

Drug: 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.

Outcome Measures

Primary Outcome Measures

Bacteriological Response (bacteriuria vs. no bacteriuria) [10-14 days after last dose of study med]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	City	State	Country	Postal Code
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
5	Waterbury	Connecticut	United States	06708
6	Ocala	Florida	United States	34474
7	Atlanta	Georgia	United States	30342
8	Roswell	Georgia	United States	30076
9	Chicago	Illinois	United States	60611
10	Hopedale	Massachusetts	United States	01747
11	New Brunswick	New Jersey	United States	08901
12	Cincinnati	Ohio	United States	45212-2787
13	Columbus	Ohio	United States	43214-1419
14	Philadelphia	Pennsylvania	United States	19107
15	Simpsonville	South Carolina	United States	29681
16	San Antonio	Texas	United States	78229
17	Norfolk	Virginia	United States	23510
18	Spokane	Washington	United States	99202
19	Salvador	Bahia	Brazil	41920 000
20	Belo Horizonte	Minas Gerais	Brazil
21	Porto Alegre	RS	Brazil	90470 340
22	Rio de Janeiro		Brazil
23	São Paulo		Brazil	04039-004
24	Calgary	Alberta	Canada	T2V 4R6
25	Edmonton	Alberta	Canada	T6G 2C8
26	Victoria	British Columbia	Canada	V8R 6T9
27	Hamilton	Ontario	Canada	L8N 1T8
28	Kingston	Ontario	Canada	K7L 2V7
29	London	Ontario	Canada	N6A 4V2
30	Toronto	Ontario	Canada	M4H 1C3
31	Toronto	Ontario	Canada	M4N 3M5
32	Chicoutimi	Quebec	Canada	G7H 1H2
33	Fleurimont	Quebec	Canada	J1H 5N4
34	Laval	Quebec	Canada	H7G 2E6
35	Quebec		Canada	G1S 2L6
36	Bergamo		Italy	24128
37	Milano		Italy	20132
38	Napoli		Italy	80131
39	Padova		Italy	35128
40	Roma		Italy	00155
41	Zapopan	Jalisco	Mexico	45170
42	Villahermosa	Tabasco	Mexico	86158
43	Monterrey		Mexico	64320
44	México D.F.		Mexico	06720
45	México, D. F.		Mexico	06700
46	México, D.F.		Mexico	07760
47	Vigo	Pontevedra	Spain	36214
48	Barcelona		Spain	08035
49	Madrid		Spain	28034
50	Sevilla		Spain	41014
51	Valencia		Spain	46009