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Background: Rapid identification of causative bacteria in treatment of acute otitis media (AOM) is of paramount importance for appropriate antibiotic use., Materials and Methods: This prospective observational study was conducted in 15 hospitals and clinics in Japan between 2018 and 2020. A new rapid antigen test kit (AOS-116), which simultaneously detects antigens for Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi), was applied for middle ear fluids (MEFs) and nasopharyngeal secretions (NPSs) in patients with moderate to severe AOM. We investigated relationship between the results of rapid test, severity at initial visit, and clinical course., Results: Regarding performance accuracy based on culture results, AOS-116 showed 1) high (>80%) sensitivity, specificity, and negative predictive value (NPV) in MEFs for both antigens, 2) high sensitivity, specificity, and positive predictive value (PPV) in NPSs for Hi antigen, and 3) high specificity, and PPV in NPSs for Sp antigen. Regarding predictive value of nasopharyngeal culture and antigen detection for causative middle ear pathogens, similar results were observed between AOS-116 and culture, which was characterized with high sensitivity and NPV for both pathogens. MEFs/NPSs positive for Hi antigen were significantly associated with eardrum findings, and severity. MEFs/NPSs positive for pneumococcal antigen were significantly associated with severity of otalgia, fever, and otorrhea. Among patients with prior antimicrobial treatment, improvement tended to be slower in cases positive for Hi than in cases negative., Conclusion: The rapid antigen detection test is useful as a decision-making tool for prescribing antimicrobial agents and may play an important role in promoting appropriate antimicrobial use., Competing Interests: Declaration of competing interest The authors declare financial support from ASAHI KASEI Corporation. Takuji Miyata and Norikazu Okamura are employees of Asahi Kasei Corporation. The funder had no role in the experimental design, implementation of the study, interpretation of the data, or decision to submit the manuscript for publication. This does not alter the authors’ adherence to any publication policies on sharing data and materials., (Copyright © 2024 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control. Published by Elsevier Ltd. All rights reserved.)

Objective: To assess the efficacy, safety, and tissue penetration of solithromycin for the treatment of otorhinolaryngological infections, we conducted three studies: a tissue penetration study with patients scheduled to undergo otorhinolaryngological tissue removal, an open-label study comprising patients with otitis media, pharyngitis, laryngitis, and tonsillitis, and a non-inferiority study compared with high-dose cefcapene-pivoxil (CFPN-PI)., Methods: Tissue penetration study; 17 patients with chronic rhinosinusitis, chronic otitis media, chronic tonsillitis, or palatine tonsillar hypertrophy, who required resection or removal of their tissue, were enrolled. Solithromycin was administered orally, and otorhinolaryngological tissues were collected 3.5-6 h after drug administration; blood was collected within 15 min before and after drug administration. The collected tissues and blood concentrations were measured at a central laboratory. Open-label study; 55 patients who were diagnosed with acute otitis media, laryngopharyngitis, or tonsillitis were enrolled. Solithromycin was administered orally 800 mg on Day 1, while on days 2-7, 400 mg of the drug was administered once daily. The primary endpoint is the clinical response at Test-of-Cure (TOC: 5-10 days after completion) Non-inferiority study; 283 patients with acute rhinosinusitis or acute exacerbation of chronic rhinosinusitis were randomized into either the solithromycin group or CFPN-PI group. Solithromycin was administered 800 mg once daily on Day 1 and 400 mg once daily while on Days 2-7 in solithromycin group, and CFPN-PI was administered 150 mg three times a day while on Days 1-7 in CFPN-PI group. The primary endpoint is the clinical response at TOC., Results: In the tissue penetration study, the tissue concentration ratios (tissue concentration/plasma concentration) of solithromycin were 4.19 in the sinonasal mucosa, 1.33 in the middle ear mucosa, and 6.12 in the palatine tonsil tissue. In the open-label study, the efficacy rates at the TOC were 97.0 % for acute otitis media, 100 % for laryngopharyngitis, and 81.8 % for tonsillitis. In the non-inferiority study comprising patients with rhinosinusitis, the efficacy rate at the TOC was 87.7 % for solithromycin and 89.7 % for CFPN-PI. The difference in the efficacy rate (95 % confidence interval) was -2.0 % (-9.4 % to 5.4 %), verifying the non-inferiority of solithromycin to CFPN-PI. The most common adverse events in patients administered solithromycin were diarrhea (20.7 %), nausea and nasopharyngitis (3.6 %,), pharyngitis and elevated hepatic function test results (3.1 %), and abnormal hepatic function (2.1 %)., Conclusion: Based on the findings, it is suggested that solithromycin is useful for the treatment of otorhinolaryngological infections., Competing Interests: Declaration of Competing Interest Yuichi Kurono has received financial support for the present manuscript and consulting fees as coordinating investigator from FUJIFILM Toyama Chemical Co., Ltd. Fumiyo Kudo has received financial support for the present manuscript and consulting fees as coordinating investigator from FUJIFILM Toyama Chemical Co., Ltd. Akira Watanabe has received financial support for the present manuscript and consulting fees as medical expert from FUJIFILM Toyama Chemical Co., Ltd. Kenji Suzuki has received financial support for the present manuscript and consulting fees as medical expert from FUJIFILM Toyama Chemical Co., Ltd., KYORIN Pharmaceutical Co., Ltd. and CEOLIA Pharma Co., Ltd. Takahiro Yamatake and Satoshi Shimada are employee of FUJIFILM Toyama Chemical Co., Ltd., (Copyright © 2023. Published by Elsevier B.V.)

Objective: "Clinical Practice Guidelines for the Diagnosis and Management of Acute Otitis Media in Children-2018 update (2018 Guidelines)" aim to provide appropriate recommendations about the diagnosis and management of children with acute otitis media (AOM), including recurrent acute otitis media (recurrent AOM), in children under 15 years of age. These evidence-based recommendations were created with the consensus of the subcommittee members, taking into consideration unique characteristics of bacteriology and antimicrobial susceptibilities of AOM pathogens in Japan, as well as global advances in vaccines., Methods: The subcommittee re-evaluated key clinical issues based on SCOPE (a master plan of the guidelines) and created clinical questions (CQ) about the diagnosis and management of AOM patients. A literature search of the publications from 2013 to 2016 were added to the Guidelines 2013, not only to assess the evidence on the effectiveness of vaccines, but also to provide up to date information of the bacteriology and antimicrobial susceptibilities of AOM causative pathogens in Japan., Results: We have proposed guidelines for disease severity-based management of AOM patients, after classifying AOM severity into mild, moderate, and severe, based on age, clinical manifestations, and otoscopic findings., Conclusions: Precise otoscopic findings are essential for judging AOM severity, which can lead to appropriate management of AOM patients., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: To (1) indicate methods of diagnosis and testing for childhood (<15 years) acute otitis media (AOM) and (2) recommend methods of treatment in accordance with the evidence-based consensus reached by the Subcommittee of Clinical Practice Guideline for Diagnosis and Management of AOM in Children (Subcommittee of Clinical Practice Guideline), in light of the causative bacteria and their drug sensitivity of AOM in Japan., Methods: We investigated the most recently detected bacteria causing childhood AOM in Japan as well as antibacterial sensitivity and the worldwide distinct progress of vaccination, produced Clinical Questions concerning the diagnosis, testing methods, and treatment of AOM, searched literature published during 2000-2004, and issued the 2006 Guidelines. In the 2009 and 2013 Guidelines, we performed the same investigation with the addition of literature, which were not included in the 2006 Guidelines and published during 2005-2008 and during 2009-2012, respectively., Results: We categorized AOM as mild, moderate, or severe on the basis of tympanic membrane findings and clinical symptoms, and presented recommended treatment for each degree of severity., Conclusion: Accurate assessment of tympanic membrane findings is important for judging the degree of severity and selecting a method of treatment. Some of new antimicrobial agents and pneumococcal vaccination are recommended as new treatment options., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Out of 175 pneumococcal isolates from middle ear fluids, 26.3% were penicillin-resistant S. pneumoniae (PRSP). Serotypes 19F and 23F occurred most frequently among PRSP strains. The 7-valent pneumococcal conjugate vaccine (PCV) showed better coverage of PRSP strains (87.0%). The 7-valent PCV may reduce the prevalence of PRSP in Japan.