We conducted an open clinical study of an oral carbapenem, tebipenem pivoxil (TBPM-PI), in pediatric patients with acute otitis media and acute upper respiratory tract infection to assess efficacy, safety, and drug compliance. We also assessed dosage and administration at 4 mg/kg bid and 6 mg/kg bid set based on confirmatory study results for dosage and administration in adult patients. 1. Clinical effect: Response at the end of administration or at discontinuation was 100% (12/12) in the 4 mg/kg bid group and 100% (10/ 10) in the 6 mg/kg bid group. 2. Bacteriological effect: Bacteriological effectiveness was shown for all 7 strains of causative microorganisms isolated-3 strains in the 4 mg/ kg bid group and 4 strains in the 6 mg/kg bid group - at the end of administration or at discontinuation. 3. Safety: The incidence of adverse drug reaction (subjective symptoms and objective findings) were 16.7% (2/12) in the 4 mg/kg bid group and 36.4% (4/11) in the 6 mg/kg bid group. Common adverse drug reactions included diarrhea and loose stool. In adverse drug reactions related to laboratory tests one case in the 6 mg/kg bid group showed increased AST and ALT. No cases withdrew from the study due to adverse events. 4. Pharmacokinetics and PK-PD: Pharmacokinetics were examined in 22 cases for whom plasma TBPM concentration could be measured, and increase in Cmax and AUC0-24h were noted as dosage increased. PK-PD parameters in 7 strains in 6 cases analyzed for PK-PD showed 13 to 4,810 for AUCf/MIC, 9 to 3,145 for Cmaxf/MIC, and 11 to 100% for T>MIC. 5. Drug compliance: The proportion of cases judged to be "very easy to take" or "easy to take" was 95.7%. In conclusion, clinically recommended dosage and administration of TBPM-PI in the treatment of pediatric acute otitis media and acute upper respiratory tract infection was 4 mg/kg bid.
|ジャーナル||Japanese Journal of Chemotherapy|
|出版ステータス||Published - 2009 3月|
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