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

NCT02041767 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

DRUG

Ertapenem

One single injection of 1g of ertapenem before surgery

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier Lortholary, Md, PhD · Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres

  • Marc-Olivier Timsit, Md, PhD · Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-01-31
Completion
2015-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041767 on ClinicalTrials.gov