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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ertapenem

Criteria

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>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