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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection |
|
| group B | Experimental | One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertapenem | Drug | One single injection of 1g of ertapenem before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prostatic concentration of ertapenem | To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery | at the time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Lortholary, Md, PhD | Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres | Study Chair |
| Marc-Olivier Timsit, Md, PhD | Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEGP Hospital | Paris | 75908 Cedex 15 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15117925 | Background | 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. | |
| 12183244 | Background | 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. |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| 12100914 | Background | 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. |
| 15150185 | Background | 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. |
| 26544316 | Result | Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer J, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit M. Concentrations plasmatiques et intra-prostatiques d'ertapeneme apres administration preoperatoire : experience prospective monocentrique - etude ERTAPRO. Prog Urol. 2015 Nov;25(13):775. doi: 10.1016/j.purol.2015.08.121. No abstract available. French. |
| 27324263 | Result | Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer JM, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit MO. Plasma and intraprostatic concentrations of ertapenem following preoperative single dose administration: a single-centre prospective experience and clinical implications-the ERTAPRO study. Int J Antimicrob Agents. 2016 Aug;48(2):168-74. doi: 10.1016/j.ijantimicag.2016.04.027. Epub 2016 Jun 2. |
| D052801 |
| Male Urogenital Diseases |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |