AAAOM Primary outcomes dataset

Menzies School of Health Research

Dataset description

Demographics - Location (by Northern Territory region) - Ethnicity (all Australian First Nations) Baseline / randomisation characteristics (Table 1 in publication) - Birth characteristics (birth weight, gestational age, maternal smoking) - Randomisation characteristics (weight, age, breastfeeding status, household smoking, environmental smoke, family history 'runny ears') Randomisation allocation (treatment group) and treatment given Otitis media diagnosis at baseline, 1 week, 2 weeks and 4 weeks. Additional antibiotic management data (clinical failure) in the 2 week intervention period. Basic microbiologic data from nasopharyngeal swabs and ear discharge.
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Source Study

Trial acronym


Trial ID





Phase 3 / Phase 4


Government body,National Health and Medical Research Council

Scientific enquiries

Andre Wattiaux

Brief Summary

The primary aim of this study is to evaluate whether azithromycin compared with no treatment results in a reduction in the proportion of children with signs of persistent disease 14 days after starting treatment.

Key Inclusion Criteria

1. Informed consent obtained and signed 2. All Aboriginal children aged 6 months and 30 months of age on the date of randomisation who are resident in participating communities will be eligible to be screened for asymptomatic acute otitis media without perforation. 3. The following inclusion criteria for the randomized controlled trial (RCT) will be applied to children diagnosed with asymptomatic acute otitis media: a.) A bulging tympanic membrane. b.) No associated symptoms at the time of diagn ....
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Key Exclusion Criteria

1. Acute otitis media with ear pain or fever 2. Acute otitis media with recent onset of perforation and discharge (within 7 days) 3. Chronic suppurative otitis media 4. Previously been randomised into this study 5. Have received antibiotics in the previous 7 days (not including topical antibiotics) 6. A more severe illness requiring antibiotics 7. Azithromycin allergy 8. Immunodeficiency

Can healthy volunteers participate?




Sample Size    300

Min. age    6 Months

Max. age    30 Months

Sex    Both males and females

Condition category    Acute otitis media without perforation

Condition code    Ear


Intervention code Treatment: Drugs

Two doses of 30mg/kg of azithromycin or the placebo will be adminstered a week a apart on Day 0 and Day 7. The mode of administration of the drug will be oral suspension.


Control group Placebo

The placebo is custom made to smell, taste and imitate azithromycin.


Outcome: Clinical failure (All): Proportion of children with bulging or middle ear discharge at 14 days or withdrawn due to complications or side effects. All children who are lost to follow up are considered clinical failures.
Timepoint: 14 days after commencement of intervention

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see