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

Phase 4CompletedNCT02041767

Assistance Publique - Hôpitaux de Paris20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Interventions

ErtapenemDRUG

One single injection of 1g of ertapenem before surgery

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

HEGP Hospital

Paris, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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