Vol.57 No.S-1 March 2009
PK-PD analysis of tebipenem pivoxil in clinical trials for pediatric patients
1)Department of Infectious Diseases, Tokyo Women's Medical University, 8-1 Kawada, Shinjuku-ku, Tokyo, Japan
2)Clinical Research Department, Meiji Seika Kaisha, LTD.
3)Department of Pharmacology, Jikei University School of Medicine
4)Department of Pediatrics, National Hospital Organization Tokyo Medical Center
5)Laboratory of Infectious Diseases Science, Graduate School of Infection Control Sciences, Kitasato University
Abstract
We conducted PK-PD analysis of tebipenem pivoxil(TBPM-PI), an oral carbapenem antibiotic and TBPM prodrug, in clinical studies of pediatric patients.
We analyzed 86 strains isolated from 70 subjects whose plasma TBPM concentration and the MIC of causative organisms had been measured. We studied the target PK-PD parameter based on the relationship between PK-PD parameters and bacteriological or clinical efficacy.
Eradication was high, with only one strain persisting. The presumed target of AUCf/MIC was 6. We did not find a clear relationship between Cmaxf/MIC or T>MIC and bacteriological efficacy.
We investigated PK-PD analysis of TBPM-PI in clinical study for pediatric patients. And we calculated the presumed target PK-PD parameter at which TBPM-PI was expected to show the efficacy. This is very useful in using TBPM-PI appropriately.
Key word
tebipenem pivoxil, child, PK-PD
Received
October 28, 2008
Accepted
February 26, 2009
Jpn. J. Chemother. 57 (S-1): 186-191, 2009
