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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00539149
Other study ID # COMIT1
Secondary ID NHMRC 954086
Status Completed
Phase Phase 4
First received October 2, 2007
Last updated May 21, 2010
Start date April 1996
Est. completion date March 2001

Study information

Verified date October 2007
Source Menzies School of Health Research
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date March 2001
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 12 Months
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Amoxycillin
50 mg/kg/day twice daily
Placebo equivalent to amoxycillin
50 mg/kg/d twice daily

Locations

Country Name City State
Australia Menzies School of Health Research Darwin Northern Territory

Sponsors (2)

Lead Sponsor Collaborator
Menzies School of Health Research National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (6)

Coates HL, Morris PS, Leach AJ, Couzos S. Otitis media in Aboriginal children: tackling a major health problem. Med J Aust. 2002 Aug 19;177(4):177-8. — View Citation

Leach AJ, Morris PS, Smith-Vaughan H, Mathews JD. In vivo penicillin MIC drift to extremely high resistance in Serotype 14 Streptococcus pneumoniae persistently colonizing the nasopharynx of an infant with chronic suppurative lung disease: a case study. A — View Citation

Leach AJ, Morris PS. Antibiotics for the prevention of acute and chronic suppurative otitis media in children. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004401. Review. — View Citation

Leach AJ, Morris PS. Perspectives on infective ear disease in indigenous Australian children. J Paediatr Child Health. 2001 Dec;37(6):529-30. Review. — View Citation

Morris PS, Leach AJ, Halpin S, Mellon G, Gadil G, Wigger C, Mackenzie G, Wilson C, Gadil E, Torzillo P. An overview of acute otitis media in Australian Aboriginal children living in remote communities. Vaccine. 2007 Mar 22;25(13):2389-93. Epub 2006 Sep 22. — View Citation

Morris PS, Leach AJ, Silberberg P, Mellon G, Wilson C, Hamilton E, Beissbarth J. Otitis media in young Aboriginal children from remote communities in Northern and Central Australia: a cross-sectional survey. BMC Pediatr. 2005 Jul 20;5:27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of children with middle ear effusion end of intervention
Primary Proportion of study visits at which middle ear effusion detected during intervention
Secondary Proportion of infants with tympanic membrane perforation end of intervention
Secondary Proportion of study visits with tympanic membrane perforation during intervention
Secondary Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae end of intervention
Secondary proportion of infants withdrawn from study due to intervention adverse events end of intervention
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