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

NCT00539149 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2010-05-24

No results posted yet for this study

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

Interventions

DRUG

Amoxycillin

50 mg/kg/day twice daily

DRUG

Placebo equivalent to amoxycillin

50 mg/kg/d twice daily

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • John D Mathews, PhD, DSc. · Menzies School of Health Research and University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1996-04-30
Completion
2001-03-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539149 on ClinicalTrials.gov