HEGP Hospital
Paris, 75908 Cedex 15, France
NCT Number: NCT02041767
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
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Notify Me18 year–80 year
Male
Interventional
Phase 4
Paris, 75908 Cedex 15, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One single injection of 1g of ertapenem before surgery
Time frame: at the time of surgery
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
To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ERTAPRO
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