Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00294749
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.	Drug: Ciprofloxacine	Phase 3

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Apr 1, 2008

Outcome Measures

Primary Outcome Measures

1. Bacteriuria five days after prostate biopsy []

Secondary Outcome Measures

1. - Clinically diagnosed infectious complications []

2. - Other complications related to the procedure []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Poitiers Hospital University	Poitiers		France	86000

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

• Principal Investigator: Irani Jacques, professor,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00294749
• Other Study ID Numbers: 2005-005959-17
• First Posted: Feb 22, 2006
• Last Update Posted: Jan 27, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Prostate,; Infection,; Biopsy,; Antibiotic,; Prophylaxis
• Additional relevant MeSH terms: Prostatic Neoplasms; Ciprofloxacin

Study Results

No Results Posted as of Jan 27, 2009