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

Condition(s) targeted: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Intervention: Ertapenem (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Olivier Lortholary, Md, PhD, Study Chair, Affiliation: Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres
Marc-Olivier Timsit, Md, PhD, Principal Investigator, Affiliation: Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.

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

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Prostatic concentration of ertapenem

Secondary outcome: Prostatic concentration of ertapenem

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.

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

HEGP Hospital, Paris 75908 Cedex 15, France

Related publications:

Alhambra A, Cuadros JA, Cacho J, Gómez-Garcés JL, Alós JI. In vitro susceptibility of recent antibiotic-resistant urinary pathogens to ertapenem and 12 other antibiotics. J Antimicrob Chemother. 2004 Jun;53(6):1090-4. Epub 2004 Apr 29.

Tomera KM, Burdmann EA, Reyna OG, Jiang Q, Wimmer WM, Woods GL, Gesser RM; Protocol 014 Study Group. Ertapenem versus ceftriaxone followed by appropriate oral therapy for treatment of complicated urinary tract infections in adults: results of a prospective, randomized, double-blind multicenter study. Antimicrob Agents Chemother. 2002 Sep;46(9):2895-900.

Jimenez-Cruz F, Jasovich A, Cajigas J, Jiang Q, Imbeault D, Woods GL, Gesser RM; Protocol 021 Study Group. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults. Urology. 2002 Jul;60(1):16-22.

Wells WG, Woods GL, Jiang Q, Gesser RM. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii67-74.

Starting date: December 2013
Last updated: April 8, 2015