None listed
Conditions
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.
Interventions
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.
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Months to 30 Months
Healthy volunteers
No
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 diagnosis (including ear pain or fever). 4. Children who have a diagnosis of asymptomatic acute otitis media who are able to attend the clinic for follow up visits at day 7, day 14 and day 28.
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
Outcome results
None listed