Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy - Full Text View

Sponsored by:	Poitiers University Hospital
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00294749

Purpose

The purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy

Condition	Intervention	Phase
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.	Drug: Ciprofloxacine	Phase III

MedlinePlus related topics: Antibiotics Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:

Bacteriuria five days after prostate biopsy

Secondary Outcome Measures:

- Clinically diagnosed infectious complications
- Other complications related to the procedure

Estimated Enrollment:	300
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2006

Detailed Description:

Prophylactic antibiotic is used to minimize the infective complications risk following transrectal biopsy of the prostate.

The majority of works points to the need of antibiotic prophylaxis previously to transrectal prostate biopsy. However, there is a lot of controversy and diversity of therapeutic schemes in the literature concerning the ideal drug to be used and the time employed for infectious prophylaxis.

The objective of this randomised study was to assess 2 different schemes of antimicrobial prophylaxis, aiming to determine the difference in infective complications with a single dose of ciprofloxacin 2 hours before the procedure vs. ciprofloxacin for 3 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

abnormal digital rectal examination
abnormal PSA values

To be excluded those patients with:

ciprofloxacine contraindication
indwelling urethral catheter,
positive urine culture,
presence of cardiac valve prosthesis,
uncontrolled diabetes mellitus,
use of antimicrobials in the 7 days prior to biopsy.
Urinary endoscopic procedure in the 7 days prior to biopsy
coagulation defect
Renal insufficiency
Hepatic insufficiency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294749

Contacts

Contact: Irani Jacques, Professor	00 335 49 44 46 54	j.irani@chu-poitiers.fr
Contact: Briffaux Raphaël, Resident	00 335 49 44 46 54	rbriffaux@hotmail.com

Locations

France
Poitiers Hospital University	Recruiting
Poitiers, France, 86000
Contact: Irani Jacques, Professor 05 49 44 46 54 j.irani@chu-poitiers.fr
Contact: Briffaux Raphaël, resident 05 49 44 46 54 rbriffaux@hotmail.com
Principal Investigator: Irani Jacques, Professor
Sub-Investigator: Bruyere franck, doctor
Sub-Investigator: coloby patrick, doctor
Sub-Investigator: leremboure henri, doctor

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator:

Irani Jacques, professor

Unaffiliated.

More Information

Study ID Numbers:	2005-005959-17
Study First Received:	February 19, 2006
Last Updated:	February 19, 2006
ClinicalTrials.gov Identifier:	NCT00294749
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Poitiers University Hospital:

Prostate,
Infection,
Biopsy,
Antibiotic,
Prophylaxis

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009