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

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection Clinical Trial

— ERTAPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041767
• Other study ID #: P090205
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2014
• Last updated: January 29, 2016
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Ertapenem
One single injection of 1g of ertapenem before surgery

Locations

Country	Name	City	State
France	HEGP Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

References & Publications (4)

Alhambra A, Cuadros JA, Cacho J, Gómez-Garcés JL, Alós 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. Epub 2004 Apr 29. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostatic concentration of ertapenem	To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.	at the time of surgery	No
Secondary	Prostatic concentration of ertapenem	To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery	at the time of surgery	No