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

Phase 4

Completed

• Conditions: Otitis Media
• Interventions: Drug: Amoxycillin; Drug: Placebo equivalent to amoxycillin

• Registration Number: NCT00539149
• Lead Sponsor: Menzies School of Health Research

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 Description

Not available

Study Timeline

• Study Start: 1996-04
• Study Completion: 2001-03
• Status Verified: 2007-10
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-04
• Last Update Submitted: 2010-05-21
• Last Update Posted: 2010-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Amoxycillin	-
2	Placebo equivalent to amoxycillin	-

Primary Outcome Measures

Name	Time	Method
Proportion of children with middle ear effusion	end of intervention
Proportion of study visits at which middle ear effusion detected	during intervention

Secondary Outcome Measures

Name	Time	Method
Proportion of infants with tympanic membrane perforation	end of intervention
Proportion of study visits with tympanic membrane perforation	during intervention
Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae	end of intervention
proportion of infants withdrawn from study due to intervention adverse events	end of intervention

Trial Locations

Locations (1)

Menzies School of Health Research; 🇦🇺 Darwin, Northern Territory, Australia