Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration (NCT02041767) | Clinical Trial Compass
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 range18 Years – 80 Years
SexMALE
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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