{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T07:40:33Z","timestamp":1792482033995,"version":"4.5.0"},"reference-count":23,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T00:00:00Z","timestamp":1792195200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Otol Rhinol Laryngol"],"abstract":"\n Objective:<\/jats:title>\n The goal of this investigation was to characterize the microbiological profile and antimicrobial susceptibility patterns of pathogens isolated from AOE patients of 2 vehicle-controlled Phase III clinical trials and evaluate pathogen eradication rates achieved with finafloxacin otic suspension. In vitro MIC comparisons to other fluoroquinolones (ciprofloxacin, ofloxacin) are reported as supplementary susceptibility data and do not reflect direct randomized clinical comparisons.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n A total of 2683 bacteria isolated from 1234 AOE patients enrolled in 2 Phase III clinical studies in the United States, Puerto Rico, and Canada were analyzed. Specimens were collected from the external ear of subjects with AOE. Species-level identification for each bacterial isolate recovered was obtained by combining phenotypic and genotypic data. End point minimum inhibitory concentration (MIC) testing was performed using Clinical and Laboratory Standards Institute recommended methods.<\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n 72.7% of the pre-therapy bacteria were Gram-positive and 27.3% Gram-negative. Most frequent bacterial isolates were\n Staphylococcus<\/jats:italic>\n spp. (46.7%) followed by\n Pseudomonas<\/jats:italic>\n spp. (19.5%). Methicillin resistance was detected in 17.0% of\n S<\/jats:italic>\n .\n aureus<\/jats:italic>\n (MRSA) and 33.2% of\n S<\/jats:italic>\n .\n epidermidis<\/jats:italic>\n (MRSE) isolates. Ciprofloxacin resistance was identified in 12.5% of\n S<\/jats:italic>\n .\n aureus<\/jats:italic>\n and 14.0% of\n S<\/jats:italic>\n .\n epidermidis<\/jats:italic>\n isolates. Finafloxacin eradicated 86.4% of the MRSA isolates and 80.6% of the MRSE isolates. Finafloxacin eradicated ciprofloxacin-resistant\n Staphylococcus<\/jats:italic>\n spp. in 74.4% and ciprofloxacin-resistant\n Pseudomonas<\/jats:italic>\n spp. in 87.5% of treated patients.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n \n Finafloxacin demonstrated high eradication rates in AOE patients with methicillin-resistant\n S<\/jats:italic>\n .\n epidermidis<\/jats:italic>\n and\n S<\/jats:italic>\n .\n aureus<\/jats:italic>\n , as well as in patients with ciprofloxacin-resistant\n Staphylococcus<\/jats:italic>\n spp.- and\n Pseudomonas<\/jats:italic>\n spp., irrespective of the pathogen\u2019s resistance profile. These in vitro findings, together with observed eradication rates in the vehicle-controlled trials, suggest that finafloxacin may offer advantages in the treatment of resistant organisms, particularly under acidic pH conditions. However, direct clinical trial comparisons have not been conducted.\n <\/jats:p>\n <\/jats:sec>\n \n Trial Registration:<\/jats:title>\n \n Clinical trial registry name: ClinicalTrials.gov. URL:\n https:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n . Identifier: NCT01535599 and NCT01535560\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/00034894261496759","type":"journal-article","created":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T05:59:07Z","timestamp":1792303147000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Acute Otitis Externa\u2013Antimicrobial Resistance in the US and Canada: Phase III Study Outcomes"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-5324-9325","authenticated-orcid":false,"given":"Christine","family":"Bentley","sequence":"first","affiliation":[{"name":"MerLion Pharmaceuticals GmbH, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"L\u00fcckermann","sequence":"additional","affiliation":[{"name":"MerLion Pharmaceuticals GmbH, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Dalhoff","sequence":"additional","affiliation":[{"name":"Christian-Albrechts-University of Kiel, Institute for Infection Medicine, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4475-0217","authenticated-orcid":false,"given":"Andreas","family":"Vente","sequence":"additional","affiliation":[{"name":"MerLion Pharmaceuticals GmbH, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,17]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/000348940911801104"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/0194599813517659"},{"issue":"11","key":"e_1_3_3_4_2","first-page":"1055","article-title":"Acute otitis externa: an update","volume":"86","author":"Schaefer P","year":"2012","unstructured":"Schaefer P, Baugh RF. Acute otitis externa: an update. Am Fam Physician. 2012;86(11):1055-1061.","journal-title":"Am Fam Physician"},{"issue":"1","key":"e_1_3_3_5_2","article-title":"Interventions for acute otitis externa","volume":"2010","author":"Kaushik V","year":"2010","unstructured":"Kaushik V, Malik T, Saeed SR. Interventions for acute otitis externa. Cochrane Database Syst Rev. 2010;2010(1):CD004740.","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0262806"},{"key":"e_1_3_3_7_2","volume-title":"Performance Standards for Antimicrobial Susceptibility Testing, M100","author":"CLSI","year":"2021","unstructured":"CLSI. Performance Standards for Antimicrobial Susceptibility Testing, M100, 31st ed. Clinical and Laboratory Standards Institute; 2021.","edition":"31"},{"key":"e_1_3_3_8_2","first-page":"1222","article-title":"Acute otitis externa in children","volume":"58","author":"McWilliams CJ","year":"2011","unstructured":"McWilliams CJ, Smith CH, Goldman RD. Acute otitis externa in children. Can Fam Physician. 2011;58:1222-1224.","journal-title":"Can Fam Physician"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/00005537-200207000-00005"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.wjorl.2017.09.003"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1177\/0194599814528301"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid1710.101365"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1101\/cshperspect.a025288"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.52142\/omujecm.39.2.11"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000001966"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.40.8.1881"},{"key":"e_1_3_3_17_2","volume-title":"48th ICAAC\/46th IDSA","author":"Muller MT","year":"2008","unstructured":"Muller MT, Stubbings W, Vente A. Comparative activity between finafloxacin (FIN) and other fluoroquinolones against bacterial and eukaryotic Type II topoisomerases. In 48th ICAAC\/46th IDSA, Washington DC, 2008; F1-2046."},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0022215118000191"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2011.03.002"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1111\/coa.14071"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.3390\/antibiotics11050606"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2022.1067284"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.165.15.1756"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2011.616192"}],"container-title":["Annals of Otology, Rhinology & Laryngology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/00034894261496759","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/00034894261496759","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/00034894261496759","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T07:20:47Z","timestamp":1792480847000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/00034894261496759"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,17]]},"references-count":23,"alternative-id":["10.1177\/00034894261496759"],"URL":"https:\/\/doi.org\/10.1177\/00034894261496759","relation":{},"ISSN":["0003-4894","1943-572X"],"issn-type":[{"value":"0003-4894","type":"print"},{"value":"1943-572X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,17]]},"article-number":"00034894261496759"}}