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. (COMIT1)

NCT00539149 Phase 4 COMPLETED

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.

Details

Lead sponsor	Menzies School of Health Research
Phase	Phase 4
Status	COMPLETED
Enrolment	126
Start date	1996-04
Completion	2001-03

Conditions

• Otitis Media

Interventions

• Amoxycillin
• Placebo equivalent to amoxycillin

Primary outcomes

• Proportion of children with middle ear effusion — end of intervention
• Proportion of study visits at which middle ear effusion detected — during intervention

Countries

Australia