Clinical trial NCT00539149: Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Otitis Media
Keywords: Acute otitis media
Otitis media with effusion
Tympanic membrane perforation
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2007-10-04
Enrollment: 126
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Proportion of children with middle ear effusion
timeFrame: end of intervention
measure: Proportion of study visits at which middle ear effusion detected
timeFrame: during intervention
Secondary outcomes:
measure: Proportion of infants with tympanic membrane perforation
timeFrame: end of intervention
measure: Proportion of study visits with tympanic membrane perforation
timeFrame: during intervention
measure: Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae
timeFrame: end of intervention
measure: proportion of infants withdrawn from study due to intervention adverse events
timeFrame: end of intervention
Other outcomes:
Locations:
city: Darwin
country: Australia
facility: Menzies School of Health Research
state: Northern Territory
Study officials:
affiliation: Menzies School of Health Research and University of Melbourne
name: John D Mathews, PhD, DSc.
role: PRINCIPAL_INVESTIGATOR
References:
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;2006(4):CD004401. doi: 10.1002/14651858.CD004401.pub2.
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.
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.
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.
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.
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.