Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children (COMIT1)

Menzies School of Health Research

Status and phase: Completed; Phase 4

Conditions: Otitis Media

Treatments: Drug: Placebo equivalent to amoxycillin; Drug: Amoxycillin

Study type: Interventional

Funder types: Other

Identifiers

NCT00539149

NHMRC 954086

COMIT1

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Amoxycillin

2

Placebo Comparator group

Treatment:

Drug: Placebo equivalent to amoxycillin