Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
Status:
Completed
Trial end date:
2001-03-01
Target enrollment:
Participant gender:
Summary
This clinical trial was conducted in a population where tympanic membrane perforation occurs
in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination)
with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear
infection throughout childhood. The trial aimed to assess whether twice daily antibiotics
commencing at first detection of middle ear effusion would cure the infection and/or prevent
disease progression, compared to placebo.
The study was conducted in three remote Aboriginal communities in the Northern Territory of
Australia. The annual birth cohort was 45.
Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until
middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent,
infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to
24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled
examinations. At monthly examinations the infant also had a general health check, parents
were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were
collected.
Phase:
Phase 4
Details
Lead Sponsor:
Menzies School of Health Research
Collaborator:
National Health and Medical Research Council, Australia