Clinical trial NCT02041767: Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Official title: Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
Keywords: Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-01-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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\<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

Primary outcomes:
measure: Prostatic concentration of ertapenem
timeFrame: at the time of surgery
Secondary outcomes:
measure: Prostatic concentration of ertapenem
timeFrame: at the time of surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP Hospital
Study officials:
affiliation: Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres
name: Olivier Lortholary, Md, PhD
role: STUDY_CHAIR
affiliation: Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.
name: Marc-Olivier Timsit, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alhambra A, Cuadros JA, Cacho J, Gomez-Garces JL, Alos 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. doi: 10.1093/jac/dkh218. Epub 2004 Apr 29.
citation: 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. doi: 10.1128/AAC.46.9.2895-2900.2002.
citation: 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. doi: 10.1016/s0090-4295(02)01664-3.
citation: 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. doi: 10.1093/jac/dkh208.