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

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT00539149
First received: October 2, 2007
Last updated: May 21, 2010
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Otitis Media
Drug: Amoxycillin
Drug: Placebo equivalent to amoxycillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • Proportion of children with middle ear effusion [ Time Frame: end of intervention ]
  • Proportion of study visits at which middle ear effusion detected [ Time Frame: during intervention ]

Secondary Outcome Measures:
  • Proportion of infants with tympanic membrane perforation [ Time Frame: end of intervention ]
  • Proportion of study visits with tympanic membrane perforation [ Time Frame: during intervention ]
  • Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae [ Time Frame: end of intervention ]
  • proportion of infants withdrawn from study due to intervention adverse events [ Time Frame: end of intervention ]

Enrollment: 126
Study Start Date: April 1996
Study Completion Date: March 2001
Arms Assigned Interventions
Active Comparator: 1 Drug: Amoxycillin
50 mg/kg/day twice daily
Placebo Comparator: 2 Drug: Placebo equivalent to amoxycillin
50 mg/kg/d twice daily

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00539149

Locations
Australia, Northern Territory
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0811
Sponsors and Collaborators
Menzies School of Health Research
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: John D Mathews, PhD, DSc. Menzies School of Health Research and University of Melbourne
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00539149     History of Changes
Other Study ID Numbers: COMIT1, NHMRC 954086
Study First Received: October 2, 2007
Last Updated: May 21, 2010
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Menzies School of Health Research:
Acute otitis media
Otitis media with effusion
Tympanic membrane perforation

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014