Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children (COMIT1)
Primary Purpose
Otitis Media
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Amoxycillin
Placebo equivalent to amoxycillin
Sponsored by
About this trial
This is an interventional prevention trial for Otitis Media focused on measuring Acute otitis media, Otitis media with effusion, Tympanic membrane perforation
Eligibility 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
Sites / Locations
- Menzies School of Health Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Proportion of children with middle ear effusion
Proportion of study visits at which middle ear effusion detected
Secondary Outcome Measures
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proportion of infants withdrawn from study due to intervention adverse events
Full Information
NCT ID
NCT00539149
First Posted
October 2, 2007
Last Updated
May 21, 2010
Sponsor
Menzies School of Health Research
Collaborators
National Health and Medical Research Council, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00539149
Brief Title
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Menzies School of Health Research
Collaborators
National Health and Medical Research Council, Australia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Acute otitis media, Otitis media with effusion, Tympanic membrane perforation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxycillin
Intervention Description
50 mg/kg/day twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo equivalent to amoxycillin
Intervention Description
50 mg/kg/d twice daily
Primary Outcome Measure Information:
Title
Proportion of children with middle ear effusion
Time Frame
end of intervention
Title
Proportion of study visits at which middle ear effusion detected
Time Frame
during intervention
Secondary Outcome Measure Information:
Title
Proportion of infants with tympanic membrane perforation
Time Frame
end of intervention
Title
Proportion of study visits with tympanic membrane perforation
Time Frame
during intervention
Title
Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae
Time Frame
end of intervention
Title
proportion of infants withdrawn from study due to intervention adverse events
Time Frame
end of intervention
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Mathews, PhD, DSc.
Organizational Affiliation
Menzies School of Health Research and University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menzies School of Health Research
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
0811
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17054203
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. doi: 10.1002/14651858.CD004401.pub2.
Results Reference
background
PubMed Identifier
17030497
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. doi: 10.1016/j.vaccine.2006.09.006. Epub 2006 Sep 22.
Results Reference
background
PubMed Identifier
16033643
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. doi: 10.1186/1471-2431-5-27.
Results Reference
background
PubMed Identifier
11903828
Citation
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.
Results Reference
background
PubMed Identifier
12175319
Citation
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.
Results Reference
background
PubMed Identifier
12384383
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. Antimicrob Agents Chemother. 2002 Nov;46(11):3648-9. doi: 10.1128/AAC.46.11.3648-3649.2002.
Results Reference
result
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Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
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