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Completed

NCT Number: NCT02041767

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

HEGP Hospital

Paris, 75908 Cedex 15, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertapenem

Drug

One single injection of 1g of ertapenem before surgery

Primary outcomes

  1. Prostatic concentration of ertapenem

    Time frame: 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 outcomes

  1. Prostatic concentration of ertapenem

    Time frame: at the time of surgery

    To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: ERTAPRO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2014
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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