Pharmacokinetic study of ertapenem in the biliary tract

Abstract number: 1734_8

Skiada A., Chardaloubas D., Dimitroulis D., Smyrnis A., Anyfantis J., Grammatikou M., Petrikkou E., Papachristodoulou A., Petrikkos G.

Objectives: Ertapenem has been licensed for the treatment of community acquired pneumonia, acute gynaecological infections and intra-abdominal infections, including biliary tract infections. However, pharmacokinetic data on biliary tract tissues are limited. The purpose of this study was to measure the levels of ertapenem in the bile, the gallbladder wall and the surrounding tissues of the biliary tract as well as the kinetics of the drug.

Patients and Methods: Adult patients undergoing elective cholecystectomy were included in the study, after giving informed consent. Patients who had renal, hepatic or cardiac failure, as well as patients with an active infection, were excluded. Two doses of ertapenem of 1gr were administered via intravenous infusion of 30 minutes duration to all patients, divided by a 24 h interval. Specimen of the bile, the wall of the gall-bladder as well as of other tissues of the biliary tract were taken intraoperatively. The specimen were obtained at various time intervals (0, 2, 4, 8, 12, 18 post administration of the second dose of the drug). Serum levels of the drug were measured simultaneously. Agar well microbiology diffusion method was used for determination of drug level.

Results: Twenty-six patients were initially enrolled in the study, but eight were dropped out. Eighteen patients, 11 female and 7 male, with an average age of 54 years (range 28 to 65) were evaluated. After administration of ertapenem no serious adverse experiences were observed. Serum samples were taken from 16 patients, bile samples from 18 and gallbladder tissue from 7. The concentrations of ertapenem in the gallbladder tissues were noted to be lower as the time interval between administration of the second dose of ertapenem and tissue sampling increased. However, no such trend emerged regarding the concentrations in bile and serum. The measured ertapenem concentrations in the bile and the bile-to-plasma concentration ratio showed a broad variation. The concentrations of ertapenem in serum ranged from 0.07 to 181 mg/L, with no clear correlation with the times of infusion of ertapenem. The same was true for concentrations in the bile, which ranged from 0.31 to 389 mg/L.

Conclusions: Concentrations of ertapenem in bile and serum vary considerably from patient to patient. Since the sample was relatively small, it would be interesting to extend it to include more patients in order to better analyse the results.

Session Details

Date: 31/03/2007
Time: 00:00-00:00
Session name: European Society of Clinical Microbiology and Infectious Diseases
Location: ICC, Munich, Germany
Presentation type:
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