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Study 4 of 11 for search of: | Australia, Northern Territory |
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Sponsors and Collaborators: |
Menzies School of Health Research National Health and Medical Research Council, Australia |
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Information provided by: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT00539149 |
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 |
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Otitis Media |
Drug: Amoxycillin Drug: Placebo equivalent to amoxycillin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Enrollment: | 126 |
Study Start Date: | April 1996 |
Study Completion Date: | March 2001 |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Amoxycillin
50 mg/kg/day twice daily
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2: Placebo Comparator |
Drug: Placebo equivalent to amoxycillin
50 mg/kg/d twice daily
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Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Australia, Northern Territory | |
Menzies School of Health Research | |
Darwin, Northern Territory, Australia, 0811 |
Principal Investigator: | John D Mathews, PhD, DSc. | Menzies School of Health Research and University of Melbourne |
Study ID Numbers: | COMIT1, NHMRC 954086 |
Study First Received: | October 2, 2007 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00539149 |
Health Authority: | Australia: National Health and Medical Research Council |
Acute otitis media Otitis media with effusion Tympanic membrane perforation |
Amoxicillin Otorhinolaryngologic Diseases Otitis Media with Effusion Otitis |
Otitis Media Tympanic Membrane Perforation Ear Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |