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Trial registered on ANZCTR


Registration number
ACTRN12609000691246
Ethics application status
Approved
Date submitted
15/01/2009
Date registered
12/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Azithromycin versus Amoxicillin for Treatment of Acute otitis media in Aboriginal Children (AATAAC)
Scientific title
In Indigenous children aged 6 months to 6 years with a diagnosis of acute otitis media, does Azithromycin given as a single dose (compared to 7 days of standard dose amoxicillin) result in a reduction in the proportion of children with signs of persistent disease after treatment?
Universal Trial Number (UTN)
Trial acronym
AATAAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute otitis media in Indigenous children aged 6 months to 6 years 4201 0
Condition category
Condition code
Ear 4411 4411 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of the macrolide antibiotic azithromycin 30mg/kg administered orally. Placebo syrup identical in smell, taste and apprearance was used in a doubel dummy fashion.
Intervention code [1] 3916 0
Treatment: Drugs
Comparator / control treatment
Amoxicillin 50 mg/kg/day twice a day administered orally for minimum of 7 days, 14 days for a diagnosis of acute otitis media (AOM) with perforation. persistent infection was referred to local health care providers for standard treatment. Placebo syrup identical in smell, taste and apprearance was used in a doubel dummy fashion.
Control group
Active

Outcomes
Primary outcome [1] 5295 0
Clinical failure: Proportion of children with persistent pain or bulging or middle ear discharge or withdrawn due to complications or side effects. Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [1] 5295 0
day 6 to 11 post commencement of treatment
Primary outcome [2] 5296 0
Clinical failure: Proportion of children with active perforation. Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [2] 5296 0
day 6 to 11 post commencement of treatment
Secondary outcome [1] 8911 0
Clinical failure (symptomatic): proportion of children with peristent ear pain or middle ear discharge.Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [1] 8911 0
day 6 to 11 post commencement of treatment
Secondary outcome [2] 8912 0
Clinical failure (by follow up): proportion of children with peristent ear pain or bulging or middle ear discharge or withdrawn due to complications or side effects (children lost to follow up excluded). Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [2] 8912 0
day 6 to 11 post commencement of treatment
Secondary outcome [3] 8913 0
Clinical failure (by treatment received): proportion of children with peristent ear pain or bulging or middle ear discharge or withdrawn due to complications or side effects (children whoreceived 80% of recommended medications).Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [3] 8913 0
day 6 to 11 post commencement of treatment
Secondary outcome [4] 8914 0
Failure to improve (all) Proportion of children with no improvement(children lost to follow up assumed to be failures).Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [4] 8914 0
day 6 to 11 post commencement of treatment
Secondary outcome [5] 8915 0
Failure to improve (by follow up): Proportion of children with no improvement (children lost to follow up excluded). Assessment by health care professionals using video otoscopy and tympanometry and standardised.
Timepoint [5] 8915 0
day 6 to 11 post commencement of treatment
Secondary outcome [6] 8916 0
Complications: proportion of children withdrawn due to complications. Assessed by review of child's medical records. Complications may include diarrhoea, vomiting.
Timepoint [6] 8916 0
day 6 to 11 post commencement of treatment
Secondary outcome [7] 8917 0
Side Effects: proportion of children withdrawn due to side effects (such as gastrointestinal upset). Assessed by review of child's medical records for indication that child's health carer had recommended cessation of the trial medication following side effects.
Timepoint [7] 8917 0
day 6 to 11 post commencement of treatment
Secondary outcome [8] 8918 0
Antibiotic resistance; Proportion of children with carriage of resistant bacterial pathogen. Assessed using E-test to measure minimum inhibitory concentration and recommended breakpoints.
Timepoint [8] 8918 0
day 6 to 11 post commencement of treatment

Eligibility
Key inclusion criteria
Aboriginal. Betwen age 6 mo and 6 years. New diagnosis of acute otitis media (AOM) without perforation or AOM with perforation. Children willing to attend for follow-up at day 6 to 11, and day 12-21 for children with perforation.
Minimum age
6 Months
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Randomised previously in the same study. Received antibiotics in the previous 7 dyas. Current severe illness requiring intravenous or intramuscualar antibiotics within the next 7 days. Allergy to penicillin or azithromycin. Perforation in affected ear(s) greater than 2%

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)
All age eligible children in the remote community received screening ear examination. Those who met inclusion criteria were invited to participate. Allocation was concealed by means of double sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Varying block sizes. Allocation was stratified according to i)health centre ii) child's weight iii) diagnosis of AOM (with or without perforation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
double dummy placebo. Placebos were identical in smell, taste and appearance to the active medications.
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4385 0
Government body
Name [1] 4385 0
National Health and Medical Research Council (NHMRC)
Address [1] 4385 0
POBox 1421
Canberra 2601
ACT
Country [1] 4385 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
POBox 1421
Canberra 2601
ACT
Country
Australia
Secondary sponsor category [1] 3944 0
None
Name [1] 3944 0
Address [1] 3944 0
Country [1] 3944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6433 0
Human Research Ethics Committee (HREC) of Northern Territory Department of Health and Families and Menzies School of Health Research
Ethics committee address [1] 6433 0
C/- Menzies School of Health Research
POBox 41096 Casuarina NT. 0811
Ethics committee country [1] 6433 0
Australia
Date submitted for ethics approval [1] 6433 0
Approval date [1] 6433 0
Ethics approval number [1] 6433 0
02/44

Summary
Brief summary
The purpose of the study is to determine whether single dose azithromycin is superior to standard therapy (7 days amoxicillin) in resolving acute otitis media in Aboriginal children at high risk of tympanic membrane perforation.
Trial website
none
Trial related presentations / publications
not yet published
Public notes

Contacts
Principal investigator
Name 35093 0
Address 35093 0
Country 35093 0
Phone 35093 0
Fax 35093 0
Email 35093 0
Contact person for public queries
Name 12440 0
A/Prof Amanda J Leach
Address 12440 0
PO Box 41096
Casuarina. 0811
NT
Country 12440 0
Australia
Phone 12440 0
+61 8 89228196
Fax 12440 0
+61 8 89275 187
Email 12440 0
amanda@menzies.edu.au
Contact person for scientific queries
Name 3368 0
A/Prof Amanda J Leach
Address 3368 0
PO Box 41096
Casuarina. 0811
NT
Country 3368 0
Australia
Phone 3368 0
+61 8 89228196
Fax 3368 0
+61 8 89275 187
Email 3368 0
amanda@menzies.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary