Vol.57 No.S-1 March 2009
Double-blind comparative study of tebipenem pivoxil and high-dose cefditoren pivoxil in children with acute otitis media (Phase III)
1)Department of Otolaryngology, The Second Hospital, Fujita Health University, 3-6-10 Otobashi, Nakagawa-ku, Nagoya, Aichi, Japan
2)Nagoya City University Medical School
3)Department of Infectious Diseases, Tokyo Women's Medical University
4)Department of Pharmacology, Jikei University School of Medicine
5)Laboratory of Molecular Epidemiology for Infectious Agents, Graduate School of Infection Control Sciences, Kitasato University
6)Hamamatsu Institute of Clinical Pharmacology & Therapeutics
7)Laboratory of Infectious Diseases Science, Graduate School of Infection Control Sciences, Kitasato University
Abstract
We conducted a double-blind comparative study to assess efficacy and safety of tebipenem pivoxil(TBPM-PI), a new carbapanem antibiotic, in children with acute otitis media, setting high-dose cefditoren pivoxil(CDTR-PI) as the control.
TBPM-PI was administered orally at 4 mg/kg (≥3.5 mg/kg-<5.0 mg/kg) 2 times daily and high-dose CDTR-PI (≥4.2 mg/kg-<6.0 mg/kg) 3 times daily for 7 days.
1. Clinical efficacy
Efficacy analysis at the end of treatment in 204 subjects was 98.2% (108/110) in the TBPM-PI group and 92.6% (87/94) in the high-dose CDTR-PI group, demonstrating the noninferiority of TBPM-PI to high-dose CDTR-PI.
2. Bacteriological efficacy
In 125 of 204 subjects, we determined 138 strains of causative organisms. In subjects evaluable for bacteriological efficacy, eradication 3 days after administration was 98.2% (55/56) in the TBPM-PI group and 80.3% (53/66) in the high-dose CDTR-PI group. Eradication at the end of treatment was 100% (69/69) in the TBPM-PI group and 98.5% (64/65) in the high-dose CDTR-PI group.
3. Safety
The incidence of adverse drug-related reactions associated with subjective symptoms and objective findings in 212 subjects analyzed for safety was 15.3% (17/111) in the TBPM-PI group and 13.9% (14/101) in the high-dose CDTR-PI group. The incidence of adverse drug-related reactions associated with abnormal changes in laboratory data was 1.8% (2/109) in the TBPM-PI group and 7.4% (7/94) in the high-dose CDTR-PI group.
Our results suggest that 4 mg/kg of TBPM-PI administered 2 times daily for 7 days is clinically useful in pediatric acute otitis media treatment.
Key word
acute otitis media, double blind trial, tebipenem pivoxil, cefditoren pivoxil, oral carbapenem
Received
September 26, 2008
Accepted
December 19, 2008
Jpn. J. Chemother. 57 (S-1): 167-185, 2009
