A Phase 4 interventional study of Ertapenem in Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Prevention
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
Ertapenem is an antibiotic belonging to carbapenems family and used in infections with Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance.
The purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection.
Patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia.
Concentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery.
To demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC) for 40% of the time of injection interval.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 20 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection
Drug: Ertapenem
One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
Drug: Ertapenem
One single injection of 1g of ertapenem before surgery
Prostatic concentration of ertapenem
To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.
Time frame: at the time of surgery
Prostatic concentration of ertapenem
To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery
Time frame: at the time of surgery
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris