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

January 29, 2016 updated by: Assistance Publique - Hôpitaux de Paris
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75908 Cedex 15
        • HEGP Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection
Drug: Ertapenem
One single injection of 1g of ertapenem before surgery
Experimental: group B
One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
Drug: Ertapenem
One single injection of 1g of ertapenem before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Olivier Lortholary, Md, PhD, Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres
  • Principal Investigator: Marc-Olivier Timsit, Md, PhD, Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P090205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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