Otitis MediaPhase 4COMIT1NCT00539149
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
A Phase 4 study testing Amoxycillin in people with Otitis Media, run by Menzies School of Health Research at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media
- What is being tested?
- Amoxycillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 1996to Mar 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Australian Aboriginal
- Living in participating remote community
- Less than 12 months of age
Who cannot join
- Less than 32 weeks gestation
- Chronic condition requiring continuous antibiotic
- Ear, nose or throat abnormality
Trial locations and contacts
1 site in 1 country.
Australia1 site
Menzies School of Health Research
Darwin, Northern Territory, 0811
About this 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.
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
- Being tested
- Amoxycillin, Placebo equivalent to amoxycillin
- Keywords
- Acute otitis media, Otitis media with effusion, Tympanic membrane perforation
- Medical subject headings
- Otitis Media, Otitis Media with Effusion, Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxycillinDrug
50 mg/kg/day twice daily
Placebo equivalent to amoxycillinDrug
50 mg/kg/d twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Amoxycillin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo equivalent to amoxycillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with middle ear effusion
Measured: end of intervention
Proportion of study visits at which middle ear effusion detected
Measured: during intervention
Secondary outcomes (4)
Proportion of infants with tympanic membrane perforation
Measured: end of intervention
Proportion of study visits with tympanic membrane perforation
Measured: during intervention
Proportion of infants with nasopharyngeal colonisation with resistant Streptococcus pneumoniae
Measured: end of intervention
proportion of infants withdrawn from study due to intervention adverse events
Measured: end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startApr 1996
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- John D Mathews, PhD, DSc., Principal investigator, Menzies School of Health Research and University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539149
- Sponsor's protocol ID
- COMIT1
- Other IDs
- NHMRC 954086
- Acronym
- COMIT1
- Status last verified
- Oct 2007
- First submitted
- 2 Oct 2007
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leach AJ, Morris PS. Antibiotics for the prevention of acute and chronic suppurative otitis media in children. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD004401. doi: 10.1002/14651858.CD004401.pub2.
PubMed 17054203Morris 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. doi: 10.1016/j.vaccine.2006.09.006. Epub 2006 Sep 22.
PubMed 17030497Morris 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. doi: 10.1186/1471-2431-5-27.
PubMed 16033643Leach AJ, Morris PS. Perspectives on infective ear disease in indigenous Australian children. J Paediatr Child Health. 2001 Dec;37(6):529-30. doi: 10.1046/j.1440-1754.2001.00729.x.
PubMed 11903828Coates 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. doi: 10.5694/j.1326-5377.2002.tb04727.x. No abstract available.
PubMed 12175319Leach 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. Antimicrob Agents Chemother. 2002 Nov;46(11):3648-9. doi: 10.1128/AAC.46.11.3648-3649.2002.
PubMed 12384383Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Antibiotics for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD015254. doi: 10.1002/14651858.CD015254.pub2.
PubMed 37870130
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00539149
- Acronym / sponsor ID
- COMIT1 / COMIT1
- Conditions
- Otitis Media
- Keywords
- Acute otitis media, Otitis media with effusion, Tympanic membrane perforation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Apr 1996
- Study completion
- Mar 2001 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Amoxycillin |
| 2 | Placebo comparator | Drug: Placebo equivalent to amoxycillin |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Australian Aboriginal
- Living in participating remote community
- Less than 12 months of age
Key exclusion criteria (3 listed)
- Less than 32 weeks gestation
- Chronic condition requiring continuous antibiotic
- Ear, nose or throat abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxycillin50 mg/kg/day twice daily | Drug | 1 |
| Placebo equivalent to amoxycillin50 mg/kg/d twice daily | Drug | 2 |
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
- Background: PubMed 17054203Leach AJ, Morris PS. Antibiotics for the prevention of acute and chronic suppurative otitis media in children. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD004401. doi: 10.1002/14651858.CD004401.pub2.
- Background: PubMed 17030497Morris 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. doi: 10.1016/j.vaccine.2006.09.006. Epub 2006 Sep 22.
- Background: PubMed 16033643Morris 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. doi: 10.1186/1471-2431-5-27.
- Background: PubMed 11903828Leach AJ, Morris PS. Perspectives on infective ear disease in indigenous Australian children. J Paediatr Child Health. 2001 Dec;37(6):529-30. doi: 10.1046/j.1440-1754.2001.00729.x.
- Background: PubMed 12175319Coates 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. doi: 10.5694/j.1326-5377.2002.tb04727.x. No abstract available.
- Results publication: PubMed 12384383Leach 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. Antimicrob Agents Chemother. 2002 Nov;46(11):3648-9. doi: 10.1128/AAC.46.11.3648-3649.2002.
- Derived from this study: PubMed 37870130Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Antibiotics for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD015254. doi: 10.1002/14651858.CD015254.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Mathews, PhD, DSc. principal investigator
Menzies School of Health Research and University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxycillin in people with Otitis Media, run by Menzies School of Health Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with middle ear effusion (time frame: end of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00539149, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2010.