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Trial registered on ANZCTR


Registration number
ACTRN12624000247572
Ethics application status
Approved
Date submitted
25/01/2024
Date registered
13/03/2024
Date last updated
13/03/2024
Date data sharing statement initially provided
13/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Azithromycin at birth: Single dose azithromycin shortly before birth - what is the impact on infection rates in high-risk mothers and babies? A randomised controlled trial
Scientific title
Azithromycin at birth: Single dose azithromycin shortly before birth - what is the impact on infection rates in high-risk mothers and babies? A randomised controlled trial
Secondary ID [1] 311415 0
None
Universal Trial Number (UTN)
Trial acronym
A@B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
maternal post-natal infections 332695 0
infant infections 332696 0
Condition category
Condition code
Reproductive Health and Childbirth 329405 329405 0 0
Childbirth and postnatal care
Infection 329406 329406 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single 2g dose of oral azithromycin in the 24 hours prior to birth
Intervention code [1] 327852 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled - capsule with maize starch
Control group
Placebo

Outcomes
Primary outcome [1] 337223 0
Maternal infection requiring antibiotic intervention
Timepoint [1] 337223 0
6 weeks after birth
Primary outcome [2] 337224 0
Infant infection requiring antibiotic intervention
Timepoint [2] 337224 0
6 weeks after birth
Secondary outcome [1] 431110 0
Rates of serious adverse effects (SAEs) in mothers
Timepoint [1] 431110 0
Assessed at birth, day 7, and 6 weeks post birth.
Secondary outcome [2] 431111 0
Neonatal weight gain
Timepoint [2] 431111 0
6 weeks of age
Secondary outcome [3] 431112 0
Neonatal admission to hospital
Timepoint [3] 431112 0
6 weeks of age
Secondary outcome [4] 431113 0
Length of stay for birth (mothers)
Timepoint [4] 431113 0
6 weeks post birth or when mother leaves hospital (if longer)
Secondary outcome [5] 431114 0
Post-natal maternal nasopharyngeal bacterial colonisation
Timepoint [5] 431114 0
Birth, day 7 and 6 weeks after birth
Secondary outcome [6] 431115 0
Post-natal neonatal nasopharyngeal bacterial colonisation
Timepoint [6] 431115 0
Birth, day 7 and 6 weeks after birth
Secondary outcome [7] 431116 0
Antibiotic resistance in nasopharyngeal pathogens from maternal nasopharyngeal swabs
Timepoint [7] 431116 0
Birth, day 7, and 6 weeks post birth
Secondary outcome [8] 431669 0
Rates of serious adverse effects (SAEs) in babies
Timepoint [8] 431669 0
Assessed at birth, day 7, and 6 weeks post birth.
Secondary outcome [9] 431672 0
Length of stay for birth (mothers)
Timepoint [9] 431672 0
6 weeks post birth or when infant leaves hospital (if longer)
Secondary outcome [10] 432698 0
Antibiotic resistance in nasopharyngeal pathogens from infant nasopharyngeal swabs
Timepoint [10] 432698 0
Birth, day 7, and 6 weeks post birth.

Eligibility
Key inclusion criteria
1. Age greater than or equal to 16 years of age
2. Pregnant Northern Territory Aboriginal and / or Torres Strait Islander women
3. Pregnant non-Indigenous women who have an operative or preterm birth (27-36 weeks)
4. Birthing at Royal Darwin Hospital
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously randomised
2. Azithromycin treatment within the last 7 days
3. Lack of access to a primary health provider in the NT
4. Allergy or hypersensitivity to azithromycin
5. Not able to provide informed consent
6. Gestation <26 weeks
7. Not available for assessment at 6 weeks
8. Women whose primary clinician intends to treat with azithromycin
9. A diagnosis of chorioamnionitis or intrapartum sepsis prior to randomisation with broad spectrum antibiotics planned for >48-72hrs

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified by location of residence (urban vs remote)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The co-primary clinical outcome analysis will report the difference in proportion (and 95% confidence interval) of mothers and babies with a new clinical infection requiring treatment with antibiotics. Crude differences in clinical infection will be assessed by chi squared test. We will adjust for stratification factors using a binomial regression model. Risk difference (RD) and relative risk (RR) estimates and 95% confidence interval (CI) will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/02/2024
Date of last participant enrolment
Anticipated
31/10/2026
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
1548
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 26082 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 41937 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 315675 0
Government body
Name [1] 315675 0
National Health and Medical Research Council
Country [1] 315675 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Australia
Secondary sponsor category [1] 317781 0
None
Name [1] 317781 0
Address [1] 317781 0
Country [1] 317781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314554 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 314554 0
https://www.menzies.edu.au/page/About_Us/Menzies_committees/Human_research_ethics_committee/
Ethics committee country [1] 314554 0
Australia
Date submitted for ethics approval [1] 314554 0
04/05/2022
Approval date [1] 314554 0
06/06/2022
Ethics approval number [1] 314554 0
22-4323

Summary
Brief summary
This trial will assess whether a single dose of azithromycin (or placebo) given shortly before birth will reduce maternal and infant infections requiring antibiotic intervention in the 6 weeks following the birth, Pregnant women will be randomised close to time of delivery, and followed up for 6 weeks. Nasopharyngeal and vaginal swabs will be collected to monitor the impact of azithromycin on colonisation and resistance. Primary outcome assessment of new infections will be done by review of clinical presentations at primary health care and hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131994 0
Prof Peter Morris
Address 131994 0
Menzies School of Health Research, Bld 58, RDH Campus, Rocklands Road, Tiwi, NT 0810
Country 131994 0
Australia
Phone 131994 0
+61889468600
Fax 131994 0
Email 131994 0
[email protected]
Contact person for public queries
Name 131995 0
Dr Jemima Beissbarth
Address 131995 0
Menzies School of Health Research, Bld 58, RDH Campus, Rocklands Road, Tiwi, NT 0810
Country 131995 0
Australia
Phone 131995 0
+61889468506
Fax 131995 0
Email 131995 0
[email protected]
Contact person for scientific queries
Name 131996 0
Dr Jemima Beissbarth
Address 131996 0
Menzies School of Health Research, Bld 58, RDH Campus, Rocklands Road, Tiwi, NT 0810
Country 131996 0
Australia
Phone 131996 0
+61889468506
Fax 131996 0
Email 131996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographics, risk factors, primary outcomes
When will data be available (start and end dates)?
January 2028 - no end date known
Available to whom?
Researchers willing to engage in collaborative ongoing work via application process, with HREC approval through the HREC of the Northern Territory Government Department of Health and Menzies School of Health Research, following the Menzies policies for secondary data use.
Available for what types of analyses?
Any purpose, following the Menzies policies for secondary data use, with appropriate approvals.
How or where can data be obtained?
Via application after Jan 2027, through Health Data Australia, https://researchdata.edu.au/health/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.