A open clinical trial study of tebipenem pivoxil fine granule for treatment of pediatric patients with otorlaryngological infections

We conducted a phase II open clinical study in pediatric patients with acute otitis media and acute rhinosinusitis to assess efficacy, safety, and drug compliance with TBPM-PI 4 mg/kg bid and 6 mg/kg bid administration. 1. Clinical effect: Efficacy at the end of administration or at discontinuation was 100% (11/11) in the 4 mg/kg bid group and 100% (10/ 10) in the 6 mg/kg bid group, showing good clinical effect in all subjects. 2. Bacteriological effect: Isolated causal microorganisms were 5 strains of Streptococcus pneumoniae, 4 strains of Haemophilus influenzae, and 2 strains of Moraxella catarrhalis. Eradication at the end of administration or at discontinuation was 90.9% (10/11) in all subjects. All strains excluding 1 strain of H. influenzae in the 6 mg/kg bid were eradicated. 3. Safety: The incidence of adverse drug reactions associated with subjective symptoms and objective findings was 28.0% (7/25) in all subjects, consisting of 33.3% (4/12) in the 4 mg/kg bid and 23.1% (3/13) in the 6 mg/kg. Common adverse drug reactions were diarrhea and loose stool. No adverse drug reactions were associated with clinical laboratory tests in any treatment group. 4. Drug compliance: Compliance was 96.0% (24/25) in both treatment groups, i.e., 100% (12/12) in the 4 mg/kg bid group and 92.3% (12/13) in the 6 mg/kg bid group. Compliance in the age group of ≥ 3 years old and < 6 years old was 92.9% (13/14) and 100% (11/11) in the age group of < 3 years old. Sufficient clinical and bacteriological effects were noted in the 4 mg/ kg bid group of the dose converted by that from the adult study, and no specific clinical problem occurred in safety. The recommended clinical dose for pediatric patients with acute otitis media and acute rhinosinusitis was therefore 4 mg/kg bid.