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.
Lowe J, Gillespie D, Hubbard M, et al. BMJ Open. 2020;10:e041528.
The published protocol describes the rationale, eligibility criteria, intervention, outcomes, microbiological sampling and trial procedures.
Kotecha SJ, Course CW, Jones KE, Watkins WJ, Berrington J, Gillespie D, Kotecha S. Trials. 2022;23:796.
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.
Lau TMM, Lowe J, Pickles T, Hood K, Kotecha S, Gillespie D. Trials. 2022;23:704.
The pre-specified analysis plan defines the primary and secondary clinical analyses before completion of the trial.
Lowe J, Watkins WJ, Edwards MO, et al. Pediatric Infectious Disease Journal. 2014;33:697–702.
This updated meta-analysis helped establish the biological and clinical rationale for adequately powered intervention studies.
Lowe J, et al. The Lancet Respiratory Medicine. 2024;12:608–618.
The definitive primary trial report presents the clinical effectiveness and safety findings from AZTEC.
Lowe J, Gillespie D, Aboklaish A, et al. Health Technology Assessment. 2026;30(12):1–17.
The NIHR report integrates the clinical trial and programme findings and provides the full commissioned assessment.
Gallacher DJ, Zhang L, Aboklaish AF, Mitchell E, Wach R, Marchesi JR, Kotecha S. Pediatric Research. 2024;95:205–212.
This study established that azithromycin-resistant organisms and macrolide-resistance genes were already common in the preterm gut microbiota early in life.
Aboklaish AF, Watkins WJ, Gallacher D, Consoli C, Lowe J, Marchesi JR, Kotecha S. Thorax. 2026. Online ahead of print.
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.