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

NCT00539149 | Completed Phase 4 DMC

• 2 other identifiers: COMIT1NHMRC 954086
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media

Keywords

Acute otitis media; Otitis media with effusion; Tympanic membrane perforation

Outcome Measures

Primary Outcomes (2)

• Proportion of children with middle ear effusion

  end of intervention

• Proportion of study visits at which middle ear effusion detected

  during intervention

Secondary Outcomes (4)

• 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• proportion of infants withdrawn from study due to intervention adverse events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

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Amoxycillin

2

PLACEBO COMPARATOR

Drug: Placebo equivalent to amoxycillin

Interventions

Amoxycillin DRUG

50 mg/kg/day twice daily

1

Placebo equivalent to amoxycillin DRUG

50 mg/kg/d twice daily

2

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Australian Aboriginal
• Living in participating remote community
• Less than 12 months of age

You may not qualify if:

• Less than 32 weeks gestation
• Chronic condition requiring continuous antibiotic
• Ear, nose or throat abnormality

Sponsors & Collaborators

• Menzies School of Health Research: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Menzies School of Health Research

Darwin, Northern Territory, 0811, Australia

Location

Related Publications (7)

• 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.

  PMID: 17054203 BACKGROUND

• 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.

  PMID: 17030497 BACKGROUND

• 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.

  PMID: 16033643 BACKGROUND

• 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.

  PMID: 11903828 BACKGROUND

• 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.

  PMID: 12175319 BACKGROUND

• 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.

  PMID: 12384383 RESULT

• 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.

  PMID: 37870130 DERIVED

MeSH Terms

Conditions

Otitis Media; Otitis Media with Effusion; Tympanic Membrane Perforation

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John D Mathews, PhD, DSc.

  Menzies School of Health Research and University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 4, 2007
• Study Start: April 1, 1996
• Study Completion: March 1, 2001
• Last Updated: May 24, 2010

Record last verified: 2007-10

Locations

AU (1)