Antibtiotics for Asymptomatic Acute Otitis Media
A double blind placebo-controlled randomized clinical trial of the use of oral azithromycin in Aboriginal children between 6 months and 30 months of age presenting with asymptomatic acute otitis media without perforation
Menzies School of Health Research
300 participants
Mar 31, 2007
Interventional
Conditions
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.
Eligibility
Inclusion Criteria5
- Informed consent obtained and signed
- 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.
- a.) A bulging tympanic membrane.
- b.) No associated symptoms at the time of diagnosis (including ear pain or fever).
- 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 Criteria8
- Acute otitis media with ear pain or fever
- Acute otitis media with recent onset of perforation and discharge (within 7 days)
- Chronic suppurative otitis media
- Previously been randomised into this study
- Have received antibiotics in the previous 7 days (not including topical antibiotics)
- A more severe illness requiring antibiotics
- Azithromycin allergy
- Immunodeficiency
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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.
Locations(1)
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ACTRN12608000424303