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

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
• Interventions: Drug: Ertapenem

• Registration Number: NCT02041767
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Primary Completion: 2015-01
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Ertapenem	One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
group A	Ertapenem	One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection

Primary Outcome Measures

Name	Time	Method
Prostatic concentration of ertapenem	at the time of surgery	To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.

Secondary Outcome Measures

Name	Time	Method
Prostatic concentration of ertapenem	at the time of surgery	To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery

Trial Locations

Locations (1)

HEGP Hospital; 🇫🇷 Paris, France