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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Treatments: Drug: Ertapenem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02041767

P090205

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

group A

Experimental group

Description:

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

Treatment:

Drug: Ertapenem

group B

Experimental group

Description:

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

Treatment:

Drug: Ertapenem