Otitis Media
Conditions
Keywords
Acute otitis media, Otitis media with effusion, Tympanic membrane perforation
Brief 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.
Interventions
DRUGAmoxycillin
50 mg/kg/day twice daily
DRUGPlacebo equivalent to amoxycillin
50 mg/kg/d twice daily
Sponsors
National Health and Medical Research Council, Australia
Menzies School of Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children with middle ear effusion | end of intervention |
| Proportion of study visits at which middle ear effusion detected | during intervention |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of infants with tympanic membrane perforation | end of intervention |
| Proportion of study visits with tympanic membrane perforation | during intervention |
| Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae | end of intervention |
| proportion of infants withdrawn from study due to intervention adverse events | end of intervention |
Countries
Australia
Outcome results
None listed