CompletedPhase 4

Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration

France20 participantsStarted 2013-12

Plain-language summary

The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.

Who can participate

Age range

18 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acceptance and understanding of the consent form (signed) * 18-80 years old patients * BPH needing endoscopic resection according to French Urology Association recommendations * Procedure and follow up made in investigator center * normal digital rectal examination * PSA : * patient \> 69 years old, not necessary * patient \< 69 years old, PSA\<20 and if 4\<PSA\<20, the ratio free PSA/total PSA must be \>10% * patient with renal clearance \>60 estimated with MDRD * patient affiliated to the social security Exclusion Criteria: * personal or familial history of prostatic or genito-urinary cancer * personal history of pelvic irradiation * personal history of hormone-therapy * personal history of prostatic adenomectomy by abdominal approach * personal history of allergy to beta-lactamines * urinary tract infection or bacterial colonisation at the time of procedure * carbapenems treatment in the two weeks before surgery * hyperresponsivness to ertapenem or other carbapenems antibiotic * patient with renal clearance estimated with MDRD \<60 * patient with catheter or probe permanently

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prostatic concentration of ertapenem

Timeframe: at the time of surgery

Trial details

NCT IDNCT02041767

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection trials