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

NCT02041767 | Completed Phase 4

• 1 other identifier: P090205
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Keywords

Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

• Prostatic concentration of ertapenem

  To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.

  at the time of surgery

Secondary Outcomes (1)

• Prostatic concentration of ertapenem

  at the time of surgery

Study Arms (2)

group A

EXPERIMENTAL

One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection

Drug: Ertapenem

group B

EXPERIMENTAL

One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection

Drug: Ertapenem

Interventions

Ertapenem DRUG

One single injection of 1g of ertapenem before surgery

group A; group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acceptance and understanding of the consent form (signed)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Merck Sharp & Dohme LLC: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

HEGP Hospital

Paris, 75908 Cedex 15, France

Location

Related Publications (6)

• Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer J, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit M. Concentrations plasmatiques et intra-prostatiques d'ertapeneme apres administration preoperatoire : experience prospective monocentrique - etude ERTAPRO. Prog Urol. 2015 Nov;25(13):775. doi: 10.1016/j.purol.2015.08.121. No abstract available. French.

  PMID: 26544316 BACKGROUND

• Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer JM, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit MO. Plasma and intraprostatic concentrations of ertapenem following preoperative single dose administration: a single-centre prospective experience and clinical implications-the ERTAPRO study. Int J Antimicrob Agents. 2016 Aug;48(2):168-74. doi: 10.1016/j.ijantimicag.2016.04.027. Epub 2016 Jun 2.

  PMID: 27324263 BACKGROUND

• 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.

  PMID: 15117925 BACKGROUND

• 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.

  PMID: 12183244 BACKGROUND

• 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.

  PMID: 12100914 BACKGROUND

• 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.

  PMID: 15150185 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Olivier Lortholary, Md, PhD

  Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres

  STUDY CHAIR

• Marc-Olivier Timsit, Md, PhD

  Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

FR (1)