Prevention of Influenza Like-illness among Australian Hajj pilgrims

Pilot individual-cluster randomised controlled trial to test the effectiveness of masks in preventing transmission of influenza-like illness among Australian pilgrims at Hajj

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001007729

Enrollment

802

Registered

2013-09-11

Start date

2011-11-04

Completion date

2011-11-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Yes

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

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.

Outcome results