Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000424303
Ethics application status
Approved
Date submitted
23/07/2008
Date registered
25/08/2008
Date last updated
28/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antibtiotics for Asymptomatic Acute Otitis Media
Scientific title
A double blind placebo-controlled randomized clinical trial of the use of oral azithromycin in Aboriginal children between 6 months and 30 months of age presenting with asymptomatic acute otitis media without perforation
Universal Trial Number (UTN)
Trial acronym
AAAOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute otitis media without perforation 3414 0
Condition category
Condition code
Ear 3565 3565 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two doses of 30mg/kg of azithromycin or the placebo will be adminstered a week a apart on Day 0 and Day 7. The mode of administration of the drug will be oral suspension.
Intervention code [1] 3142 0
Treatment: Drugs
Comparator / control treatment
The placebo is custom made to smell, taste and imitate azithromycin.
Control group
Placebo

Outcomes
Primary outcome [1] 4468 0
Clinical failure (All): Proportion of children with bulging or middle ear discharge at 14 days or withdrawn due to complications or side effects. All children who are lost to follow up are considered clinical failures.
Timepoint [1] 4468 0
14 days after commencement of intervention
Secondary outcome [1] 7540 0
Comparison of two treatment groups for proportion of children with unresolved bulging at 7 days (on treatment assessment)
Timepoint [1] 7540 0
Day 7 after commencement of intervention
Secondary outcome [2] 7541 0
Comparison of two treatment groups for proportion of children with unresolved bulging at 30 days (end of follow up assessment)
Timepoint [2] 7541 0
Day 30 after commencement of intervention
Secondary outcome [3] 7542 0
Proportion of children with bulging or middle ear discharge or withdrawn due to complications or side effects. Not including children who are lost to follow up.
Timepoint [3] 7542 0
Day 0, 7, 14 and 30
Secondary outcome [4] 7543 0
Proportion of children who develop an illness requiring additional medical treatment
Timepoint [4] 7543 0
Day 0, 7, 14 and 30
Secondary outcome [5] 7544 0
Proportion of children who develop an illness requiring cessation of prescribed antibiotics
Timepoint [5] 7544 0
Between Day 0 and day 30
Secondary outcome [6] 7545 0
Proportion of children who have no improvement in other conditions recorded like skin sores and rhinosinusitis
Timepoint [6] 7545 0
Day 7, 14 and 30
Secondary outcome [7] 7546 0
Microbiological outcomes including carriage and antibiotic resistance of Streptococcus pneumoniae and Haemophilus influenzae
Timepoint [7] 7546 0
Day 0, 7, 14 and 30

Eligibility
Key inclusion criteria
1. Informed consent obtained and signed

2. All Aboriginal children aged 6 months and 30 months of age on the date of randomisation who are resident in participating communities will be eligible to be screened for asymptomatic acute otitis media without perforation.

3. The following inclusion criteria for the randomized controlled trial (RCT) will be applied to children diagnosed with asymptomatic acute otitis media:
a.) A bulging tympanic membrane.
b.) No associated symptoms at the time of diagnosis (including ear pain or fever).

4. Children who have a diagnosis of asymptomatic acute otitis media who are able to attend the clinic for follow up visits at day 7, day 14 and day 28.
Minimum age
6 Months
Maximum age
30 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute otitis media with ear pain or fever
2. Acute otitis media with recent onset of perforation and discharge (within 7 days)
3. Chronic suppurative otitis media
4. Previously been randomised into this study
5. Have received antibiotics in the previous 7 days (not including topical antibiotics)
6. A more severe illness requiring antibiotics
7. Azithromycin allergy
8. Immunodeficiency

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment procedures: The random assignment to treatment is kept in a series of sequentially numbered sealed opaque envelopes. Once a child has met the eligibility criteria and the parent/carer signed the consent form, the next sequentially numbered sealed opaque is opened by the study project officer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This random sequence is computer generated (Stata Version 8.0) by the IT Division of the Menzies School of Health Research
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3636 0
Government body
Name [1] 3636 0
National Health and Medical Research Council
Country [1] 3636 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Menzies School of Health Research
Address
Royal Darwin Hospital Campus,
Casuarina, NT 0810
Country
Australia
Secondary sponsor category [1] 3270 0
Government body
Name [1] 3270 0
Queensland Institute of Medical Research
Address [1] 3270 0
300 Herston Road
Herston
QLD 4006
Country [1] 3270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5690 0
The Human Research Ethics Committee of NT Department of Health and Families and Menzies School of Health Research
Ethics committee address [1] 5690 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0810
Ethics committee country [1] 5690 0
Australia
Date submitted for ethics approval [1] 5690 0
30/07/2008
Approval date [1] 5690 0
11/09/2008
Ethics approval number [1] 5690 0

Summary
Brief summary
The primary aim of this study is to evaluate whether azithromycin compared with no treatment results in a reduction in the proportion of children with signs of persistent disease 14 days after starting treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28754 0
Address 28754 0
Country 28754 0
Phone 28754 0
Fax 28754 0
Email 28754 0
Contact person for public queries
Name 11911 0
Andre Wattiaux
Address 11911 0
Menzies School of Health Research
POBox 41096
Casuarina NT 0811
Country 11911 0
Australia
Phone 11911 0
0889228649
Fax 11911 0
Email 11911 0
[email protected]
Contact person for scientific queries
Name 2839 0
Andre Wattiaux
Address 2839 0
Menzies School of Health Research
POBox 41096
Casuarina NT 0811
Country 2839 0
Australia
Phone 2839 0
0889228649
Fax 2839 0
Email 2839 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.