{"id":57,"date":"2026-08-27T13:14:44","date_gmt":"2026-08-27T13:14:44","guid":{"rendered":"https:\/\/test.rhino-health.org\/publications\/"},"modified":"2026-08-27T13:14:44","modified_gmt":"2026-08-27T13:14:44","slug":"publications","status":"publish","type":"page","link":"https:\/\/rhino-health.org\/?page_id=57","title":{"rendered":"Publications"},"content":{"rendered":"
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AZTEC publications<\/div>\n

The AZTEC evidence base<\/h1>\n

The programme spans the main trial and follow-up protocols, pre-specified statistical methods, the randomised controlled trial, the NIHR Health Technology Assessment report, and microbiology and antimicrobial-resistance analyses.<\/p>\n<\/div>\n

\"Illustration<\/div>\n<\/div>\n<\/section>\n
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Trial design & rationale<\/div>\n

Protocol, statistical methods and biological rationale<\/h2>\n
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Protocol<\/div>\n

Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC)<\/h3>\n

Lowe J, Gillespie D, Hubbard M, et al. BMJ Open<\/em>. 2020;10:e041528.<\/p>\n

The published protocol describes the rationale, eligibility criteria, intervention, outcomes, microbiological sampling and trial procedures.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n

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Follow-up protocol<\/div>\n

Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants – study protocol for the AZTEC-FU study<\/h3>\n

Kotecha SJ, Course CW, Jones KE, Watkins WJ, Berrington J, Gillespie D, Kotecha S. Trials<\/em>. 2022;23:796.<\/p>\n

The AZTEC-FU protocol specifies respiratory, neurodevelopmental, growth, mortality and safety outcomes through 2 years’ corrected age, together with linked clinical and biological-sample analyses.<\/p>\n

Read publication \u2192<\/a>   PDF \u2192<\/a><\/p>\n<\/article>\n

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Statistical analysis plan<\/div>\n

AZTEC\u2014azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes<\/h3>\n

Lau TMM, Lowe J, Pickles T, Hood K, Kotecha S, Gillespie D. Trials<\/em>. 2022;23:704.<\/p>\n

The pre-specified analysis plan defines the primary and secondary clinical analyses before completion of the trial.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n

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Systematic review<\/div>\n

Association between pulmonary Ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis<\/h3>\n

Lowe J, Watkins WJ, Edwards MO, et al. Pediatric Infectious Disease Journal<\/em>. 2014;33:697\u2013702.<\/p>\n

This updated meta-analysis helped establish the biological and clinical rationale for adequately powered intervention studies.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

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Main clinical evidence<\/div>\n

Primary AZTEC results and programme report<\/h2>\n
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Primary RCT<\/div>\n

Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a multicentre, double-blind, randomised, placebo-controlled trial<\/h3>\n

Lowe J, et al. The Lancet Respiratory Medicine<\/em>. 2024;12:608\u2013618.<\/p>\n

The definitive primary trial report presents the clinical effectiveness and safety findings from AZTEC.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n

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NIHR HTA<\/div>\n

Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a randomised placebo-controlled trial<\/h3>\n

Lowe J, Gillespie D, Aboklaish A, et al. Health Technology Assessment<\/em>. 2026;30(12):1\u201317.<\/p>\n

The NIHR report integrates the clinical trial and programme findings and provides the full commissioned assessment.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

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Antimicrobial resistance<\/div>\n

Macrolide resistance before and during AZTEC<\/h2>\n
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Baseline AMR<\/div>\n

Baseline azithromycin resistance in the gut microbiota of preterm born infants<\/h3>\n

Gallacher DJ, Zhang L, Aboklaish AF, Mitchell E, Wach R, Marchesi JR, Kotecha S. Pediatric Research<\/em>. 2024;95:205\u2013212.<\/p>\n

This study established that azithromycin-resistant organisms and macrolide-resistance genes were already common in the preterm gut microbiota early in life.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n

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Respiratory AMR<\/div>\n

Assessment of macrolide resistance in the respiratory tract of preterm-born infants during treatment with azithromycin in the AZTEC clinical trial<\/h3>\n

Aboklaish AF, Watkins WJ, Gallacher D, Consoli C, Lowe J, Marchesi JR, Kotecha S. Thorax<\/em>. 2026. Online ahead of print.<\/p>\n

Serial respiratory sampling showed that macrolide-resistance genes were common at baseline and changed little overall with azithromycin, although resistance across multiple antibiotic classes remained clinically relevant.<\/p>\n

Read publication \u2192<\/a><\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

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Explore the programme<\/div>\n

From methods to clinical and microbiological findings<\/h2>\n
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Trial results<\/h3>\n

See the primary findings explained clearly.<\/p>\n

Results \u2192<\/a><\/div>\n

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Research resources<\/h3>\n

Protocol and researcher-facing material.<\/p>\n

Researchers \u2192<\/a><\/div>\n

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Follow-up<\/h3>\n

See how the research continues beyond neonatal care.<\/p>\n

Follow-up \u2192<\/a><\/div>\n<\/div>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

AZTEC publications The AZTEC evidence base The programme spans the main trial and follow-up protocols, pre-specified statistical methods, the randomised controlled trial, the NIHR Health Technology Assessment report, and microbiology and antimicrobial-resistance analyses. Trial design & rationale Protocol, statistical methods and biological rationale Protocol Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC) […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-57","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages\/57","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhino-health.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=57"}],"version-history":[{"count":0,"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages\/57\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=57"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}