Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
  • Phase

    Phase 4
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.
Study Started
Apr 30
Study Completion
Mar 31
Last Update
May 24

Drug Amoxycillin

50 mg/kg/day twice daily

Drug Placebo equivalent to amoxycillin

50 mg/kg/d twice daily

1 Active Comparator

2 Placebo Comparator


Inclusion Criteria:

Australian Aboriginal
Living in participating remote community
Less than 12 months of age

Exclusion Criteria:

Less than 32 weeks gestation
Chronic condition requiring continuous antibiotic
Ear, nose or throat abnormality
No Results Posted