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

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.

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.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Drug: Amoxycillin; Drug: Placebo equivalent to amoxycillin

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Placebo equivalent to amoxycillin; 50 mg/kg/d twice daily
Active Comparator: 1	Drug: Amoxycillin; 50 mg/kg/day twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of children with middle ear effusion	end of intervention
Proportion of study visits at which middle ear effusion detected	during intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of infants with tympanic membrane perforation	end of intervention
Proportion of study visits with tympanic membrane perforation	during intervention
Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae	end of intervention
proportion of infants withdrawn from study due to intervention adverse events	end of intervention

Collaborators and Investigators

• Sponsor: Menzies School of Health Research
• Collaborators: National Health and Medical Research Council, Australia
• Investigators: Principal Investigator: John D Mathews, PhD, DSc., Menzies School of Health Research and University of Melbourne

Publications and helpful links

General 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. doi: 10.1002/14651858.CD004401.pub2.
• 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. doi: 10.1016/j.vaccine.2006.09.006. 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. doi: 10.1186/1471-2431-5-27.
• Leach AJ, Morris PS. Perspectives on infective ear disease in indigenous Australian children. J Paediatr Child Health. 2001 Dec;37(6):529-30. doi: 10.1046/j.1440-1754.2001.00729.x.
• 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. doi: 10.5694/j.1326-5377.2002.tb04727.x. No abstract available.
• 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. Antimicrob Agents Chemother. 2002 Nov;46(11):3648-9. doi: 10.1128/AAC.46.11.3648-3649.2002.

Study record dates

Study Major Dates

• Study Start: April 1, 1996
• Study Completion (Actual): March 1, 2001

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 2, 2007
• First Posted (Estimate): October 4, 2007

Study Record Updates

• Last Update Posted (Estimate): May 24, 2010
• Last Update Submitted That Met QC Criteria: May 21, 2010
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Acute otitis media; Otitis media with effusion; Tympanic membrane perforation
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: COMIT1; NHMRC 954086