The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 280977 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza Like-illness 287092 0
Condition category
Condition code
Public Health 287421 287421 0 0
Other public health

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285423 0
Prevention
Comparator / control treatment
No Mask
Control group
Active

Outcomes
Primary outcome [1] 287813 0
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.
Timepoint [1] 287813 0
Timepoint: for about 3 days since the first day of randomisation (4 November 2011).
Secondary outcome [1] 298871 0
Secondary outcome: Uptake of 2011 seasonal influenza vaccine.

Participants reported their uptake by filling an anonymous self-reported questionnaire.
Timepoint [1] 298871 0
Timepoint: at least 2 weeks before travel to Hajj

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
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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.

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 outside Australia
Country [1] 5395 0
Saudi Arabia
State/province [1] 5395 0
Makkah

Funding & Sponsors
Funding source category [1] 285866 0
Other Collaborative groups
Name [1] 285866 0
Saudi Arabian Ministry of Higher Education
Address [1] 285866 0
3708 Al Mathar Street, Riyadh 12712
Country [1] 285866 0
Saudi Arabia
Primary sponsor type
Hospital
Name
National Centre for Immunisation Research and Surveillance (NCIRS), the Children’s Hospital at Westmead
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.
Country
Australia
Secondary sponsor category [1] 286641 0
None
Name [1] 286641 0
Address [1] 286641 0
Country [1] 286641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289859 0
Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC)
Ethics committee address [1] 289859 0
Cnr Hawkesbury Road and Hainsworth Street,
Westmead NSW 2145
Ethics committee country [1] 289859 0
Australia
Date submitted for ethics approval [1] 289859 0
15/09/2011
Approval date [1] 289859 0
12/10/2011
Ethics approval number [1] 289859 0
11/SCHN/162

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34541 0
Prof Robert Booy
Address 34541 0
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.
Country 34541 0
Australia
Phone 34541 0
+61 2 9845 1402
Fax 34541 0
+61 2 9845 1418
Email 34541 0
robert.booy@health.nsw.gov.au
Contact person for public queries
Name 17788 0
Dr Osamah Barasheed
Address 17788 0
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.
Country 17788 0
Australia
Phone 17788 0
+61 431 103 101
Fax 17788 0
Email 17788 0
osamah.barasheed@health.nsw.gov.au
Contact person for scientific queries
Name 8716 0
Dr Harunor Rashid
Address 8716 0
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.
Country 8716 0
Australia
Phone 8716 0
+61 2 9845 1489
Fax 8716 0
+61 2 9845 1418
Email 8716 0
harunor.rashid@health.nsw.gov.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