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    An open clinical study of tebipenem pivoxil in children with acute otitis media and acute upper respiratory tract infection (phase II)
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    Upper respiratory tract infections are a frequent cause of illness. In children, acute otitis media (AOM) is the most common illness for which children receive medical attention. In adults, 20 million cases of bacterial sinusitis are reported yearly and the disease represents the fifth most common diagnosis for which an antibiotic is prescribed [1].
    Acute Otitis Media
    Respiratory tract
    Respiratory illness
    We evaluated the risk factors for refractory otitis media in children and factors related to the clinical efficacy of antimicrobial treatment using tebipenem pivoxil (TBPM-PI). Multivariate logistic regression analysis revealed that “group living” (adjusted odds ratio; 6.2, 95%CI; 1.6-24.7, P=0.010), “age under 2 years old” (adjusted odds ratio; 4.2, 95%CI; 1.5-11.3, P=0.005), and “concomitant rhinosinusitis” (adjusted odds ratio; 2.9, 95%CI; 1.1-8.1, P=0.039) were significant risk factors for refractory otitis media. In 96 cases of acute otitis media (AOM) with the risk factors of refractoriness, TBPM-PI showed clinical efficacies with 100% for patients with one of the three risk factors and with 85% for patients with two or more of the risk factors. Multivariate logistic regression analysis revealed that “concomitant rhinosinusitis” (adjusted odds ratio; 4.4, 95%CI; 1.5-13.1, P=0.008) was a significant factor related with the poor clinical efficacy of TBPM-PI treatment for AOM.Based on the results clinicians providing medical care for pediatric AOM should keep the risk factors of refractoriness in mind when selecting an appropriate treatment strategy.
    Concomitant
    Refractory (planetary science)
    Exudate
    Acute Otitis Media
    Moraxella (Branhamella) catarrhalis
    Acute Otitis Media
    Viral infection
    Respiratory infection
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