Follow up at 1 and 2 years of corrected age for participants in the AZTEC study (Azithromycin Therapy for Chronic Lung Disease of Prematurity)
| ISRCTN | ISRCTN47442783 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47442783 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 270464 |
| Protocol serial number | IRAS 270464, CPMS 44914 |
| Sponsor | Cardiff University |
| Funder | Aspire Pharma |
- Submission date
- 07/04/2022
- Registration date
- 12/04/2022
- Last edited
- 03/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Preterm birth, especially at less than 30 weeks gestation, is significantly associated with respiratory, neurodevelopmental and growth abnormalities. The AZTEC study is registered on ISRCTN (ISRCTN11650227). The AZTEC study has recruited 799 infants born at less than 30 weeks gestation to determine if a ten-day intravenous treatment with azithromycin improves survival without the development of chronic lung disease of prematurity (CLD) at 36 weeks post conceptional age (PCA) when compared to placebo. These follow-up studies will compare respiratory, neurodevelopmental, and growth outcomes from 36 weeks PCA up to 2 years of corrected age between infants who received azithromycin and those who received placebo in the early neonatal period.
Who can participate?
Survivors at 36 weeks PCA who participated in the main AZTEC study and have parental consent will continue to be followed up to discharge from the neonatal unit and to two years of corrected age.
What does the study involve?
Length of stay, rates of home oxygen, length of supplemental oxygen requirement, hospital admissions, drug usage, respiratory illness, neurodevelopmental disability, and death rates will be reported. Data will be collected via parentally completed respiratory and neurodevelopmental questionnaires at one and two years of corrected age respectively and additional information is being obtained from various sources including hospital discharge and clinical letters from general practitioners and hospitals as well as from national databases including the National Database Analyses Unit and from NHS Digital.
What are the possible benefits and risks of participating?
The study may not directly benefit the participants taking part but may lead to knowledge which could potentially help other premature babies in the future. We do not forsee any adverse events as it is a follow up study
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
From October 2019 to December 2025
Who is funding the study?
Aspire Pharma (UK)
Who is the main contact?
Professor Sailesh Kotecha
kotechas@cardiff.ac.uk
Contact information
Principal investigator
Professor Sailesh Kotecha
Department of Child Health
School of Medicine
Cardiff University
Heath Park
Cardiff
CF14 4XN
United Kingdom
| Phone | +44 (0)2920 744187 |
|---|---|
| kotechas@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | AZTEC (Azithromycin Therapy for Chronic Lung Disease of Prematurity) follow up studies: AZTEC@1 and AZTEC@2 |
| Study acronym | AZTEC@1 and AZTEC@2 |
| Study objectives | It will be important to follow these infants beyond 36 weeks’ PCA to monitor any longer-term effects from the early use of azithromycin and ensure longer-term safety. The AZTEC follow-up studies (AZTEC-FU) are assessing death rates, respiratory, neurodevelopmental, and growth outcomes for AZTEC study participants from 36 weeks PCA up to two years of corrected age; they will also document any differences in neurodevelopmental outcomes between the two trial arms. Additional mechanistic elements are investigating underlying mechanisms of azithromycin action by studying the effects of azithromycin on the lung and stool microbiome; tracheal aspirate cytokines and proteome; and antibiotic resistance against azithromycin in lung and stool samples obtained in the first three weeks of life. |
| Ethics approval(s) | Approved: 22/10/2019, Wales Research Ethics Committee 3 (Health and Care Research Support Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff CF11 9AB; +44 (0)29 2078 5735; Wales.REC3@wales.nhs.uk), ref: 19/WA/0267 |
| Health condition(s) or problem(s) studied | Prematurity |
| Intervention | In the main AZTEC study (ISRCTN11650227) infants born at <30 weeks’ gestation, within 72 h of birth, were treated intravenously for 10 days with 20 mg/kg azithromycin for 3 days, followed by a further 7 days of 10 mg/kg, or with similarly constituted and administered a placebo. This follow-up study will compare respiratory, neurodevelopmental, and growth outcomes from 36 weeks PCA up to 2 years of corrected age between infants who received azithromycin and those who received a placebo in the early neonatal period. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Azithromycin |
| Primary outcome measure(s) |
1. Respiratory outcomes measured using parent-reported wheezing at 1 year of corrected age |
| Key secondary outcome measure(s) |
1. Mortality measured using the total number of deaths occurring during the following periods: |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Participation in the AZTEC trial 2. Survival at 36 weeks PCA 3. Consent provided by the parents/guardians to be contacted for follow-up at one and two years of corrected age |
| Key exclusion criteria | 1. Withdrawal from AZTEC 2. Parents/guardians did not provide consent to follow up at one and two years corrected age 3. Death prior to 36 weeks’ PCA 4. Survival not confirmed |
| Date of first enrolment | 08/12/2020 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centre
CF14 4XW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Not expected to be made available due to existing data sharing agreements in place. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/09/2022 | 22/09/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/09/2025: The completion date was changed from 01/09/2025 to 31/12/2025.
22/09/2022: Publication reference added.
12/04/2022: Trial’s existence confirmed by Wales Research Ethics Committee 3.