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

Otitis Media Clinical Trial

— COMIT1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539149
• Other study ID #: COMIT1
• Secondary ID: NHMRC 954086
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2007
• Last updated: May 21, 2010
• Start date: April 1996
• Est. completion date: March 2001

Study information

• Verified date: October 2007
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Drug:
• Amoxycillin
50 mg/kg/day twice daily
• Placebo equivalent to amoxycillin
50 mg/kg/d twice daily

Locations

Country	Name	City	State
Australia	Menzies School of Health Research	Darwin	Northern Territory

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (6)

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. — View Citation

Leach AJ, Morris PS, Smith-Vaughan H, Mathews JD. In vivo penicillin MIC drift to extremely high resistance in Serotype 14 Streptococcus pneumoniae persistently colonizing the nasopharynx of an infant with chronic suppurative lung disease: a case study. A — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with middle ear effusion		end of intervention
Primary	Proportion of study visits at which middle ear effusion detected		during intervention
Secondary	Proportion of infants with tympanic membrane perforation		end of intervention
Secondary	Proportion of study visits with tympanic membrane perforation		during intervention
Secondary	Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae		end of intervention
Secondary	proportion of infants withdrawn from study due to intervention adverse events		end of intervention

External Links

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