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

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ClinicalTrials.gov Identifier: NCT00539149
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : May 24, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: Amoxycillin Drug: Placebo equivalent to amoxycillin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : April 1996
Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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 proportion of infants withdrawn from study due to intervention adverse events [ Time Frame: end of intervention ]

Eligibility Criteria

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539149

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
Principal Investigator: John D Mathews, PhD, DSc. Menzies School of Health Research and University of Melbourne
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00539149     History of Changes
Other Study ID Numbers: COMIT1
NHMRC 954086
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: May 24, 2010
Last Verified: October 2007

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

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents