search
Back to results

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

Primary Purpose

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ertapenem
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection focused on measuring Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • HEGP Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A

group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2014
Last Updated
January 29, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02041767
Brief Title
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Acronym
ERTAPRO
Official Title
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
Keywords
Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection
Arm Title
group B
Arm Type
Experimental
Arm Description
One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
One single injection of 1g of ertapenem before surgery
Primary Outcome Measure Information:
Title
Prostatic concentration of ertapenem
Description
To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.
Time Frame
at the time of surgery
Secondary Outcome Measure Information:
Title
Prostatic concentration of ertapenem
Description
To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery
Time Frame
at the time of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Lortholary, Md, PhD
Organizational Affiliation
Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marc-Olivier Timsit, Md, PhD
Organizational Affiliation
Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.
Official's Role
Principal Investigator
Facility Information:
Facility Name
HEGP Hospital
City
Paris
ZIP/Postal Code
75908 Cedex 15
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15117925
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.
Results Reference
background
PubMed Identifier
12183244
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.
Results Reference
background
PubMed Identifier
12100914
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.
Results Reference
background
PubMed Identifier
15150185
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs