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

Condition(s) targeted: Otitis Media

Intervention: Amoxycillin (Drug); Placebo equivalent to amoxycillin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Menzies School of Health Research

Official(s) and/or principal investigator(s):
John D Mathews, PhD, DSc., Principal Investigator, Affiliation: Menzies School of Health Research and University of Melbourne

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: 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.

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Proportion of children with middle ear effusion

Proportion of study visits at which middle ear effusion detected

Secondary outcome:

Proportion of infants with tympanic membrane perforation

Proportion of study visits with tympanic membrane perforation

Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae

proportion of infants withdrawn from study due to intervention adverse events

Minimum age: N/A. Maximum age: 12 Months. Gender(s): Both.

Criteria:

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

Menzies School of Health Research, Darwin, Northern Territory 0811, Australia

a 'one-stop shop' for people working, studying or interested in otitis media (middle ear disease) and hearing loss in the Indigenous population.

Resources for primary health care providers outlining the latest evidence on the treatment of middle ear infection in this high-risk population

Related publications:

Leach AJ, Morris PS. Antibiotics for the prevention of acute and chronic suppurative otitis media in children. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004401. Review.

Morris PS, Leach AJ, Halpin S, Mellon G, Gadil G, Wigger C, Mackenzie G, Wilson C, Gadil E, Torzillo P. An overview of acute otitis media in Australian Aboriginal children living in remote communities. Vaccine. 2007 Mar 22;25(13):2389-93. Epub 2006 Sep 22.

Morris PS, Leach AJ, Silberberg P, Mellon G, Wilson C, Hamilton E, Beissbarth J. Otitis media in young Aboriginal children from remote communities in Northern and Central Australia: a cross-sectional survey. BMC Pediatr. 2005 Jul 20;5:27.

Leach AJ, Morris PS. Perspectives on infective ear disease in indigenous Australian children. J Paediatr Child Health. 2001 Dec;37(6):529-30. Review.

Coates HL, Morris PS, Leach AJ, Couzos S. Otitis media in Aboriginal children: tackling a major health problem. Med J Aust. 2002 Aug 19;177(4):177-8. No abstract available.

Starting date: April 1996
Ending date: March 2001
Last updated: October 2, 2007