NCT00539149

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Otitis Media

Interventions

Type	Name	Description
DRUG	Amoxycillin	50 mg/kg/day twice daily
DRUG	Placebo equivalent to amoxycillin	50 mg/kg/d twice daily

Timeline

• Start date: 1996-04-01
• Completion: 2001-03-01
• First posted: 2007-10-04
• Last updated: 2010-05-24

Locations

1 site across 1 country: Australia