Title
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 4Lead Sponsor
Menzies School of Health ResearchStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Otitis MediaIntervention/Treatment
procaine benzylpenicillin amoxicillin ...Study Participants
126This 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.
50 mg/kg/day twice daily
50 mg/kg/d twice daily
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
