Clinical Trial: Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal In
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.
Detailed Summary:
Sponsor: Menzies School of Health Research
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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- proportion of infants withdrawn from study due to intervention adverse events [ Time Frame: end of intervention ]
Original Secondary Outcome: Same as current
Information By: Menzies School of Health Research
Dates:
Date Received: October 2, 2007
Date Started: April 1996
Date Completion:
Last Updated: May 21, 2010
Last Verified: October 2007
