Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: Amoxycillin
* Drug: Placebo equivalent to amoxycillin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Amoxycillin<br>* 50 mg/kg/day twice daily<br>|
| Placebo Comparator: 2<br> | Drug: Placebo equivalent to amoxycillin<br>* 50 mg/kg/d twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute otitis media, Otitis media with effusion, Tympanic membrane perforation