Vol.57 No.S-1 March 2009
General study of tebipenem pivoxil in children with acute otitis media and acute rhinosinusitis (Phase III)
1)Nagoya City University Medical School, 1 Mizuho Kawasumi, Mizuho-ku, Nagoya, Aichi, Japan
2)Department of Otolaryngology, The Second Hospital, Fujita Health University
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)Laboratory of Infectious Diseases Science, Graduate School of Infection Control Sciences, Kitasato University
Abstract
We assessed efficacy, safety, and drug compliance for a new oral carbapenem antibiotic, TBPM-PI, in pediatric patients with acute otitis media and acute rhinosinusitis. Dosage was 4 mg/kg bid, and, in recurrence or ineffective cases, 6 mg/kg bid based on symptom and severity, for 7 days.
1. Clinical effect: Efficacy in the 4 mg/kg bid group at the end of administration/at discontinuation was 98.0% (150/153) for acute otitis media and 79.2% (19/24) for acute rhinosinusitis, and in the 6 mg/kg bid group 95.8% (23/24) and 4/6.
2. Bacteriological effect: Eradication at the end of administration or at discontinuation was 99.1% (113/114) in the 4 mg/kg bid group and 100% (19/19) in the 6 mg/kg bid group. Causative microorganisms detected were 2 strains of Streptococcus pneumoniae and Haemophilus influenzae, considered primary infective strains in pediatric patients with acute otitis media and acute rhinosinusitis, occupying 92.5% of the whole.
3. Safety: Adverse drug reactions associated with subjective symptoms and objective findings were noted at 21.9% (47/215) and those associated with abnormal changes in laboratory test values at 6.2% (13/211). Common adverse drug reactions were diarrhea and loose stools, noted at 18.6% (40/215). No serious adverse events or adverse drug reactions were seen.
4. Drug compliance: Judgments of "Very easy to take" and "Easy to take" were 93.1% (201/216) in all subjects.
Results suggest sufficient clinical effects of TBPM-PI 4 mg/kg bid administration, on acute otitis media and acute rhinosinusitis and high clinical usefulness 6 mg/kg bid administration in intractable patients, including recurrence or ineffective cases in previous treatment that would be the target of treatment of acute otitis media with injectable antibiotics.
Key word
tebipenem pivoxil, acute otitis media, acute rhinosinusitis, child, oral carbapenem
Received
September 26, 2008
Accepted
January 5, 2009
Jpn. J. Chemother. 57 (S-1): 151-166, 2009
