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

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

Detailed Description
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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.

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

Conditions
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Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Intervention / Treatment
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* Drug: Ertapenem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection | Drug: Ertapenem<br>* One single injection of 1g of ertapenem before surgery<br>|
| Experimental: group B<br>One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection | Drug: Ertapenem<br>* One single injection of 1g of ertapenem before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostatic concentration of ertapenem | To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration. | at the time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostatic concentration of ertapenem | To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery | at the time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia