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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02041767

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection	Drug: Ertapenem	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Prostatic concentration of ertapenem [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HEGP Hospital	Paris		France	75908 Cedex 15

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
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.