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.
Protocol, statistical methods and biological rationale
Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC)
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.
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
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.
AZTEC—azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes
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.
Association between pulmonary Ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis
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.
Primary AZTEC results and programme report
Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a multicentre, double-blind, randomised, placebo-controlled trial
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.
Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a randomised placebo-controlled trial
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.
Macrolide resistance before and during AZTEC
Baseline azithromycin resistance in the gut microbiota of preterm born infants
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.
Assessment of macrolide resistance in the respiratory tract of preterm-born infants during treatment with azithromycin in the AZTEC clinical trial
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.