None listed
Conditions
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.
Interventions
A single 2g dose of oral azithromycin in the 24 hours prior to birth
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed