- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06247059
Reducing Respiratory Virus Transmission in Bangladeshi Classrooms
Study Overview
Status
Detailed Description
This cluster-randomized controlled trial in Bangladesh schools will examine whether low-cost air filtration and/or human-safe ultraviolet germicidal light interventions can reduce the incidence of schoolchildren's respiratory viral infections. The main study objectives are:
- Pilot and optimize an intervention to filter classroom air.
- Pilot and optimize an intervention to treat classroom air with ultraviolet light.
- Assess the separate and combined effect of air filtration and ultraviolet light on the incidence of polymerase chain reaction (PCR) confirmed illness from respiratory viruses.
Methods: The study will take place in 60 government primary schools in Dhaka, Bangladesh. Within each enrolled school, 5 classrooms of students in grades 3, 4 and 5 will be randomly assigned to receive:
- Box fans with a filter attachment.
- 220 nanometer (nm) wavelength ultraviolet light air cleaner lamps.
- Both the box fans with a filter and the 220 nm ultraviolet lamps.
- No device: a control group that receives no additional device ("standard of care"). Two classrooms within each school will be assigned as controls.
Why does this matter?: Clarifying the impact of low-cost practical solutions could support the adoption of these strategies that could reduce influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in schools in order to reduce the burden of respiratory illness in these communities.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahbubur Rahman
- Phone Number: 4003 +88 02 2222 77 001-10
- Email: Mahbubr@icddrb.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Schoolchildren of Bangladesh Government-run primary schools in Dhaka, Bangladesh ages 9 - 12 years, of all gender identifiers (male, female, transgender, prefer not to designate), without specific ethnic selection amongst standard school children of Bangladesh government schools in Dhaka, Bangladesh.
Exclusion Criteria:
- School children of non-Bangladesh Government-run primary schools and/or schoolchildren who do not attend a Bangladesh Government-run primary school in Dhaka, Bangladesh.
- School children who are not able to or have a contraindication with the ability to comply with study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Box Fan
Classrooms receive box fans equipped with a filter.
|
Classrooms assigned to this arm will be equipped with 2 - 8 box fans each with a single minimum efficiency reporting value-14 (MERV-14) filter sufficient to increase effective air changes per hour to 12 based on the clean air delivery rate measured in cubic feet per minute of the box fan + filter * 60 divided by the room volume.
|
|
Experimental: UV Germicidal Irradiation Lamp Unit
Classrooms receive UV germicidal irradiation lamp unit(s).
|
Classrooms assigned to this arm will be equipped with one or two 222nm wavelength light ultraviolet germicidal irradiation lamp units (number of units per classroom based on room volume).
|
|
Experimental: Combined: Box Fan and UV Germicidal Irradiation Lamp Units
Classrooms receive box fans equipped with a filter and UV germicidal irradiation lamp unit(s).
|
Classrooms assigned to this arm will be equipped with both box fans and UV germicidal irradiation lamp units.
|
|
No Intervention: Non-Interventional Control
Classrooms receive no intervention to their standard classroom setup.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of symptomatic respiratory illness episodes due to either Influenza or SARS- CoV-2
Time Frame: Over 40 weeks of observation
|
Study personnel will visit each school twice weekly.
They will identify any students within the study classrooms who were absent or who have symptoms consistent with the World Health Organization (WHO) definition of influenza like illness.
For children who were absent or who have symptoms, study personnel will visit the child's home, and if the student's parent provides informed consent, collect more detailed information on signs and symptoms, and a throat swab from the child.
The throat swab will be placed on viral transport media, placed on ice and transported to the One Health Laboratory at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b).
One aliquot from the specimen will be analyzed for Influenza A, Influenza B, and SARS-CoV-2.
In the laboratory, nucleic acid in the throat swab specimen will be extracted and one-step real-time (RT)-PCR conducted to assess the presence of RNA from Influenza A, Influenza B or SARS-CoV-2.
|
Over 40 weeks of observation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of symptomatic influenza-like illness episodes
Time Frame: Over 40 weeks of observation
|
Study personnel will visit each school twice weekly.
They will identify any students within the study classrooms who were absent or who have symptoms consistent with the WHO definition of influenza like illness.
|
Over 40 weeks of observation
|
|
Total number of symptomatic influenza episodes
Time Frame: Over 40 weeks of observation
|
Study personnel will visit each school twice weekly.
They will identify any students within the study classrooms who were absent or who have symptoms consistent with the WHO definition of influenza like illness.
For children who were absent or who have symptoms, study personnel will visit the child's home, and if the student's parent provides informed consent, collect more detailed information on signs and symptoms, and a throat swab from the child.
The throat swab will be placed on viral transport media, placed on ice and transported to the One Health Laboratory at icddr,b.
One aliquot from the specimen will be analyzed for Influenza A or Influenza B. In the laboratory, nucleic acid in the throat swab specimen will be extracted and one-step real-time RT-PCR conducted to assess the presence of RNA from Influenza A or Influenza B.
|
Over 40 weeks of observation
|
|
Total number of symptomatic SARS-CoV2 episodes
Time Frame: Over 40 weeks of observation
|
Study personnel will visit each school twice weekly.
They will identify any students within the study classrooms who were absent or who have symptoms consistent with the WHO definition of influenza like illness.
For children who were absent or who have symptoms, study personnel will visit the child's home, and if the student's parent provides informed consent, collect more detailed information on signs and symptoms, and a throat swab from the child.
The throat swab will be placed on viral transport media, placed on ice and transported to the One Health Laboratory at icddr,b.
One aliquot from the specimen will be analyzed for SARS-CoV2.
In the laboratory, nucleic acid in the throat swab specimen will be extracted and one-step real-time RT-PCR conducted to assess the presence of RNA from SARS-CoV2.
|
Over 40 weeks of observation
|
|
Total number of student absentee episodes
Time Frame: Over 40 weeks of observation
|
Study personnel will visit each school twice weekly.
They will identify any students within the study classrooms who were absent.
|
Over 40 weeks of observation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen P Luby, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 73657
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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