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The effects of chronic AZ in combination with TIS on the airway microbiome have not been extensively investigated. Oropharyngeal swab samples were collected in the OPTIMIZE multicenter, randomized, placebo-controlled trial examining the addition of AZ to TIS in 198 children with CF and early <jats:italic>P. aeruginosa<\/jats:italic> infection. Bacterial small subunit rRNA gene community profiles were determined. The effects of TIS and AZ were assessed on oropharyngeal microbial diversity and composition to uncover whether effects on the bacterial community may be a mechanism of action related to the observed changes in clinical outcomes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Substantial changes in bacterial communities (total bacterial load, diversity and relative abundance of specific taxa) were observed by week 3 of TIS treatment for both the AZ and placebo groups. On average, these shifts were due to changes in non-traditional CF taxa that were not sustained at the later study visits (weeks 13 and 26). Bacterial community measures did not differ between the AZ and placebo groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This study provides further evidence that the mechanism for AZ\u2019s effect on clinical outcomes is not due solely to action on airway microbial composition.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12866-023-03073-8","type":"journal-article","created":{"date-parts":[[2023,10,27]],"date-time":"2023-10-27T13:02:57Z","timestamp":1698411777000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Limited effects of azithromycin on the oropharyngeal microbiome in children with CF and early pseudomonas infection"],"prefix":"10.1186","volume":"23","author":[{"given":"Brandie D.","family":"Wagner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edith T.","family":"Zemanick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott D.","family":"Sagel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles E.","family":"Robertson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark J.","family":"Stevens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Mayer-Hamblett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Retsch-Bogart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie W.","family":"Ramsey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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Eur Respir J. 2021;57(3).","DOI":"10.1183\/13993003.01829-2020"}],"container-title":["BMC Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12866-023-03073-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12866-023-03073-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12866-023-03073-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,27]],"date-time":"2023-10-27T13:06:06Z","timestamp":1698411966000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmicrobiol.biomedcentral.com\/articles\/10.1186\/s12866-023-03073-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,27]]},"references-count":44,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["3073"],"URL":"https:\/\/doi.org\/10.1186\/s12866-023-03073-8","relation":{},"ISSN":["1471-2180"],"issn-type":[{"value":"1471-2180","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,27]]},"assertion":[{"value":"23 August 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 October 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 October 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This work is an ancillary study to the parent randomized, placebo-controlled OPTIMIZE clinical trial. Eligible participants were recruited from 45 Cystic Fibrosis Foundation\u2013accredited centers in the United States. This research was performed in accordance with the Declaration of Helsinki and was approved by each of the 45 centers institutional review boards including the Colorado Multiple Institutional Review Board (CoMIRB #14\u20130088) where the OP samples were processed (all site review boards are listed in the supplementary section). Written informed consent and HIPPA Authorization were obtained from all patients over 17 years or from parents or legal guardians of patients younger than 18 years. Assent was obtained from patients between 10 and 17 years. A DSMB monitored the trial using pre-specified stopping guidelines for efficacy and safety, further details related to participant consent and approval can be found in the trial registration (NCT02054156).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not Applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors SDS, JKH, CER and MJS declare that they have no competing interests.\u00a0BDW received honoraria for CFF DSMB participation.\u00a0NM-H received honoraria for NIH DSMB participation and consulting fees from Enterprise Therapeutics.\u00a0BWR received consulting fees from Vertex Pharmaceuticals, Cystetic Medicines and Sionna Therapeutics. Dr. Ramsey also serves as Chair of an NHLBI DSMB.\u00a0ETZ received consulting fees from Vertex Pharmaceuticals and received honoraria from CFF.\u00a0GR-B received grant funding from Vertex Pharmaceuticals.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"312"}}