Clinical trial NCT06247059: Reducing Respiratory Virus Transmission in Bangladeshi Classrooms
Official title: Reducing Respiratory Virus Transmission in Bangladeshi Classrooms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: SARS-CoV2 Infection
Influenza Viral Infections
Respiratory Viral Infection
Keywords: Bangladesh
Indoor air quality
Air cleaning
Respiratory viral infections
Influenza
SARS-CoV2
Air filtration
Ultraviolet germicidal irradiation
Global health
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2024-02-07
Enrollment: 20000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test if affordable air cleaning devices (box fans with a filter attached and/or ultraviolet light lamps) installed in classrooms can reduce the number of viral respiratory illnesses schoolchildren experience.

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:

1. Pilot and optimize an intervention to filter classroom air.
2. Pilot and optimize an intervention to treat classroom air with ultraviolet light.
3. 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:

1. Box fans with a filter attachment.
2. 220 nanometer (nm) wavelength ultraviolet light air cleaner lamps.
3. Both the box fans with a filter and the 220 nm ultraviolet lamps.
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total number of symptomatic respiratory illness episodes due to either Influenza or SARS- CoV-2
timeFrame: Over 40 weeks of observation
Secondary outcomes:
measure: Total number of symptomatic influenza-like illness episodes
timeFrame: Over 40 weeks of observation
measure: Total number of symptomatic influenza episodes
timeFrame: Over 40 weeks of observation
measure: Total number of symptomatic SARS-CoV2 episodes
timeFrame: Over 40 weeks of observation
measure: Total number of student absentee episodes
timeFrame: Over 40 weeks of observation
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Stephen P Luby, MD
role: PRINCIPAL_INVESTIGATOR
References: