Prostate drug levels checked in tiny study
NCT ID NCT02041767
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study gave 20 men with enlarged prostates a single dose of the antibiotic ertapenem before their scheduled prostate surgery. Researchers then measured how much of the drug actually reached the prostate tissue. The goal was to see if a pre-surgery dose could provide enough antibiotic to prevent infections, but the study only looked at drug levels, not infection rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ertapenem (antibiotic)
- What this could lead to
- If successful, this could show that a single pre-surgery dose of ertapenem reaches high enough levels in the prostate to help prevent infections after prostate surgery.
- What could go wrong
- This is a very small, early-phase study (20 participants) that only measures drug levels, not whether it actually prevents infections. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Dec 2013
- Finished
-
Jun 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
HEGP Hospital
Paris, 75908 Cedex 15, France
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