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Trial registered on ANZCTR
Registration number
ACTRN12613001007729
Ethics application status
Approved
Date submitted
6/09/2013
Date registered
11/09/2013
Date last updated
11/09/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Prevention of Influenza Like-illness among Australian Hajj pilgrims
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Scientific title
Pilot individual-cluster randomised controlled trial to test the effectiveness of masks in preventing transmission of influenza-like illness among Australian pilgrims at Hajj
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Secondary ID [1]
280977
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza Like-illness
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Condition category
Condition code
Public Health
287421
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
We used surgical mask (3M [TM] Standard Tie-On Surgical Mask, Cat No: 1816) manufactured by 3M company, USA.
Masks provided to intervention group ‘supervised mask use’ to use it during the Hajj week (4-10 November, 2011). Each participant provided with 5 masks per day and a brochure with instructions about mask wearing and usage. The medical researchers followed them each day to reminding participant about recording their mask usage in health diary.
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Intervention code [1]
285423
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Prevention
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Comparator / control treatment
No Mask
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary outcome: any pilgrim develop subjective fever and one symptom of influenza-like illness
During the Hajj week, everyday Muslim doctors supported by trained research nursing and public health staff visited participants in their tents to examine them and reported any symptom of of influenza-like illness.
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Assessment method [1]
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Timepoint [1]
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Timepoint: for about 3 days since the first day of randomisation (4 November 2011).
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Secondary outcome [1]
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Secondary outcome: Uptake of 2011 seasonal influenza vaccine.
Participants reported their uptake by filling an anonymous self-reported questionnaire.
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Assessment method [1]
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Timepoint [1]
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Timepoint: at least 2 weeks before travel to Hajj
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Eligibility
Key inclusion criteria
Inclusion criteria:
For Index Case:
1. Australian pilgrims of any gender aged 15 years or more who attend the Hajj 2011.
2. Have symptoms of respiratory infection for = 3 days.
For Close Tent Contact:
1. Australian pilgrims of any gender aged 15 years or more who attend the Hajj 2011, and
2. Pilgrims who share the same tent and sleep ‘immediately close’ to the index case
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria:
For Index Case:
1. Pilgrims who do not suffer from symptoms of respiratory infection.
2. Pilgrims who present with symptoms of respiratory infection for > 3 days.
3. Children aged less than 15 years.
For Close Tent Contact:
1. Pilgrims who are symptomatic at presentation
2. Pilgrims who are not close tent contacts of an index case
3. Children aged less than 15 years.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Number of contacts will vary depending on the location of the pilgrims in a tent. For most pilgrims in tents there will be at least 8 persons lying close to them, but the ones living in the far corners of the tent will have only 3 contacts around them, while the ones lying close to the wall of the tent (but not in the extreme corner) will have 5 people around them. Therefore on average every 100 index cases will have 684 contacts ([4×3+32×5+64×8]=684).
Each large tent can accommodate around 100 pilgrims–but the numbers can vary depending on the size and location of the tent, and the policy of the tour group. However, it is reasonable to estimate that there will be about 90 occupants per tents. Every year 4000-5000 Australian pilgrims travel to Hajj, so there will be about 50 tents in the Australian camp. The recruitment phase will gradually escalate since more people will become symptomatic as days pass day.
Considering the masks to be 50% effective and the secondary attack rate of influenza to be 20%, and assuming 5 index cases of ILI to be present in day 0 in each tent, 23.8% (P1) cases will be expected in intervention group and 33.6% (P2) in control group on day 4, thus 334 pilgrims should be recruited in each arm to archive 80% (B at 0.2) power of the study with a at 0.05 according to the following formula, where Z stands for ‘Z statistics’ for power:
[z1-a/2-)}+z1-Bv{P1(1-P1)+P2(1-P2)}]2÷{(P1-P2)2}.
Considering an intra-cluster co-efficient (IIC) of <0.02 we have increased the sample by a factor of 1.2 i.e, 20%. So, about 401 pilgrims need to be recruited in each arm from 10 tents making a total of 802 subjects from 20 tents: half of these should preferably be females to avoid gender bias.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/11/2011
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Actual
4/11/2011
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Date of last participant enrolment
Anticipated
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Actual
10/11/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
802
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Saudi Arabia
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State/province [1]
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Makkah
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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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Saudi Arabian Ministry of Higher Education
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Address [1]
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3708 Al Mathar Street, Riyadh 12712
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Country [1]
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Saudi Arabia
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Primary sponsor type
Hospital
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Name
National Centre for Immunisation Research and Surveillance (NCIRS), the Children’s Hospital at Westmead
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Address
National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Locked Bag 4001, Westmead NSW 2145, Australia.
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
286641
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Country [1]
286641
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC)
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Ethics committee address [1]
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Cnr Hawkesbury Road and Hainsworth Street,
Westmead NSW 2145
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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15/09/2011
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Approval date [1]
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12/10/2011
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Ethics approval number [1]
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11/SCHN/162
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Summary
Brief summary
This is a pilot trial to assess the effectiveness of face masks in the prevention of transmission of influenza-like illness (ILI), defined as subjective fever and at least one respiratory symptom, eg cough, among Australian Hajj pilgrims during the Hajj 2011. Also, we want to estimate influenza vaccine coverage rate among Australian pilgrims at the Hajj 2011 and to explore reasons for not receiving the influenza vaccine.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Robert Booy
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Address
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National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Locked Bag 4001, Westmead NSW 2145, Australia.
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Country
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Australia
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Phone
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+61 2 9845 1402
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Fax
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+61 2 9845 1418
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Osamah Barasheed
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Address
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National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Locked Bag 4001, Westmead NSW 2145, Australia.
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Country
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Australia
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Phone
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+61 431 103 101
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Harunor Rashid
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Address
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National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Locked Bag 4001, Westmead NSW 2145, Australia.
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Country
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Australia
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Phone
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+61 2 9845 1489
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Fax
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+61 2 9845 1418
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Email
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[email protected]
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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.
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