Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection Clinical Trial
Official title:
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
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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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention