{"id":56,"date":"2026-08-27T13:14:44","date_gmt":"2026-08-27T13:14:44","guid":{"rendered":"https:\/\/test.rhino-health.org\/researchers\/"},"modified":"2026-08-27T13:14:44","modified_gmt":"2026-08-27T13:14:44","slug":"researchers","status":"publish","type":"page","link":"https:\/\/rhino-health.org\/?page_id=56","title":{"rendered":"Researchers"},"content":{"rendered":"
\n
\n
\n
For researchers & clinicians<\/div>\n

AZTEC scientific resources<\/h1>\n

Trial design, statistical methods, follow-up methodology, microbiology, antimicrobial resistance and peer-reviewed publications from the AZTEC programme.<\/p>\n

View publications \u2192<\/a>Clinical results<\/a><\/div>\n<\/div>\n
\"Illustrated<\/div>\n<\/div>\n<\/section>\n
\n
\n
Trial design<\/div>\n

Multicentre, double-blind, randomised, placebo-controlled<\/h2>\n

The main AZTEC trial recruited 799 infants born before 30 weeks\u2019 gestation. Three complete withdrawals left 796 participants in the final analysis. The intervention was a 10-day course of intravenous azithromycin compared with matched placebo.<\/p>\n

\n
\n

Primary outcome<\/h3>\n

Survival without physiologically defined moderate or severe chronic lung disease at 36 weeks\u2019 postmenstrual age.<\/p>\n<\/article>\n

\n

Clinical outcomes<\/h3>\n

Neonatal morbidity, adverse events, respiratory outcomes and other clinically important endpoints.<\/p>\n<\/article>\n

\n

Mechanistic studies<\/h3>\n

Respiratory inflammation, Ureaplasma<\/em>, microbiome and antimicrobial-resistance analyses.<\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

\n
\n
Core documents<\/div>\n

Protocols and methods<\/h2>\n
\n
\n
Protocol<\/div>\n

Main AZTEC protocol<\/h3>\n

Detailed rationale, eligibility, intervention, outcomes, sampling and trial procedures.<\/p>\n

BMJ Open protocol \u2192<\/a><\/p>\n<\/article>\n

\n
Statistical analysis plan<\/div>\n

Clinical outcomes SAP<\/h3>\n

Pre-specified statistical methods for the principal clinical analyses.<\/p>\n

Trials SAP \u2192<\/a><\/p>\n<\/article>\n

\n
Follow-up protocol<\/div>\n

AZTEC-FU study protocol<\/h3>\n

Respiratory outcomes at 1 year and neurodevelopmental, growth, mortality and safety outcomes through 2 years’ corrected age.<\/p>\n

Trials protocol \u2192<\/a> \u00b7 PDF<\/a><\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

\n
\n
Microbiology & AMR<\/div>\n

A major scientific strand of AZTEC<\/h2>\n

The programme was designed not only to test clinical efficacy but also to understand the biological and antimicrobial consequences of neonatal azithromycin exposure.<\/p>\n

\n
\n

Baseline resistance<\/h3>\n

The gut microbiota of preterm infants already contained substantial macrolide resistance before or early in trial exposure, an important context for interpreting antibiotic effects.<\/p>\n<\/article>\n

\n

Respiratory resistance<\/h3>\n

Subsequent analyses examine macrolide resistance within the respiratory tract during treatment and after exposure.<\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

\n
\n
Trial archive<\/div>\n

Operational study resources<\/h2>\n

The original AZTEC website contains study guidance, data-collection forms, treatment preparation information, sampling and shipment guidance, training materials and historical newsletters. These remain useful as an archive of trial delivery.<\/p>\n

Scientific publications \u2192<\/a><\/div>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

For researchers & clinicians AZTEC scientific resources Trial design, statistical methods, follow-up methodology, microbiology, antimicrobial resistance and peer-reviewed publications from the AZTEC programme. View publications \u2192Clinical results Trial design Multicentre, double-blind, randomised, placebo-controlled The main AZTEC trial recruited 799 infants born before 30 weeks\u2019 gestation. Three complete withdrawals left 796 participants in the final analysis. […]<\/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-56","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages\/56","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=56"}],"version-history":[{"count":0,"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages\/56\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}