Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
NCT ID: NCT00539149
Last Updated: 2010-05-24
Study Results
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Basic Information
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COMPLETED
PHASE4
126 participants
INTERVENTIONAL
1996-04-30
2001-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Amoxycillin
50 mg/kg/day twice daily
2
Placebo equivalent to amoxycillin
50 mg/kg/d twice daily
Interventions
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Amoxycillin
50 mg/kg/day twice daily
Placebo equivalent to amoxycillin
50 mg/kg/d twice daily
Eligibility Criteria
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Inclusion Criteria
* Living in participating remote community
* Less than 12 months of age
Exclusion Criteria
* Chronic condition requiring continuous antibiotic
* Ear, nose or throat abnormality
12 Months
ALL
Yes
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Menzies School of Health Research
OTHER
Principal Investigators
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John D Mathews, PhD, DSc.
Role: PRINCIPAL_INVESTIGATOR
Menzies School of Health Research and University of Melbourne
Locations
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Menzies School of Health Research
Darwin, Northern Territory, Australia
Countries
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References
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Leach AJ, Morris PS. Antibiotics for the prevention of acute and chronic suppurative otitis media in children. Cochrane Database Syst Rev. 2006 Oct 18;2006(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.
Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Antibiotics for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD015254. doi: 10.1002/14651858.CD015254.pub2.
Other Identifiers
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NHMRC 954086
Identifier Type: -
Identifier Source: secondary_id
COMIT1
Identifier Type: -
Identifier Source: org_study_id
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