Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.Phase 3NCT00294749
Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy
A Phase 3 study testing Ciprofloxacine in people with Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion., run by Poitiers University Hospital at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.
- What is being tested?
- Ciprofloxacine
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abnormal digital rectal examination
- abnormal PSA values
- To be excluded those patients with:
- ciprofloxacine contraindication
- indwelling urethral catheter,
- positive urine culture,
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
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
Read the 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
- Being tested
- Ciprofloxacine
- Keywords
- Prostate,, Infection,, Biopsy,, Antibiotic,, Prophylaxis
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriuria five days after prostate biopsy
Secondary outcomes (2)
- Clinically diagnosed infectious complications
- Other complications related to the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Irani Jacques, professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294749
- Sponsor's protocol ID
- 2005-005959-17
- Other IDs
- 2005
- Status last verified
- Jan 2009
- First submitted
- 19 Feb 2006
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT00294749
- Acronym / sponsor ID
- 2005-005959-17
- Keywords
- Prostate,, Infection,, Biopsy,, Antibiotic,, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- abnormal digital rectal examination
- abnormal PSA values
- ciprofloxacine contraindication
- indwelling urethral catheter,
- positive urine culture,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacine | Drug | – |
Primary outcome
Bacteriuria five days after prostate biopsy
2 secondary outcomes
- Clinically diagnosed infectious complications
- Other complications related to the procedure
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irani Jacques, professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacine in people with Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion., run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteriuria five days after prostate biopsy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2009; AzTrials last refreshed its copy on 7 Nov 2026.