PneumoniaPLUS2NCT05724082
The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
A study testing Clean Air Intervention in people with Pneumonia and Pollution; Exposure, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
This study will evaluate the feasibility and acceptability of a household-based clean air intervention Read more about this study
- Who is it for?
- Ages 1 month to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pollution; Exposure, Lung Function Decreased
- What is being tested?
- Clean Air Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUganda
- Study dates
- 1 May 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age < 12 months
- First episode of WHO-defined severe pneumonia22: cough or difficulty breathing with
- Oxygen saturation < 90% or central cyanosis,
- Severe respiratory distress, or
- Signs of pneumonia with a general danger sign
- Be willing to commit to entire 2 years of follow up visits.
- (Controls) Matched to each case on age (+/-1 month), sex, and community
Who cannot join
- Craniofacial, cardiac or other major malformation
- Neuromuscular condition that affects respiration
- Outside Smart Discharges Project catchment area
- Prior hospitalizations or known episodes of respiratory illness or episodes of pneumonia before index admission,
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the feasibility and acceptability of a household-based clean air intervention
Read the detailed description
A clean air intervention will be implemented in each household, including HEPA- based air filtration, solar lighting, and education. The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off. To determine the effect of the clean air intervention within the household, PM2.5 concentration during each cycle and lung function will be measured among household members.
- Conditions
- Pneumonia, Pollution; Exposure, Lung Function Decreased, Chronic Respiratory Disease, Pediatric Respiratory Diseases, Lungs; Developmental Disorder
- Being tested
- Clean Air Intervention
- Medical subject headings
- Pneumonia, Respiratory Insufficiency, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clean Air InterventionOther
Based on findings from preliminary focus groups/in-depth interviews, staff will introduce various components of established clean air interventions to each household. Each household will receive interventions, depending on their known risk factors, exposures, and willingness to trial the intervention.
Study staff will ask the primary cook to complete a time-activity diary during the intervention period that includes cooking episodes, duration of cooking, stove(s) used, type of food cooked, and number of people for whom the meal was cooked. Staff will continuously monitor use of the LPG/pellet stove and any other stoves owned by the household with the Berkeley Stove Use Monitoring System, a temperature logger attached to the stove to quantify the number of stove uses / time of use . Study staff will use similar loggers to monitor use of other devices installed including the air purifiers, lighting etc.
| Study group | Role | What they receive |
|---|---|---|
| Clean air intervention | Experimental | See detailed description Receives: Other: Clean Air Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the clean intervention
Adherence with the intervention (% total up-time of the air purifier)
Measured: 2 years
Secondary outcomes (3)
Air quality
PM2.5 concentration
Measured: Up to 2 years
Pulmonary function testing
Pulmonary function testing will be performed in household members
Measured: Up to 2 years
Acceptability of using air filter device
Acceptability will be assessed using structured interviews with participating households.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 May 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Peter Moschovis, Massachusetts General Hospital
- Investigators
- Peter Moschovis, MD, Principal investigator, Massachusetts General HospitalJerome Kabakyenga, MBChB, MPH, PhD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724082
- Sponsor's protocol ID
- 2019P000649
- Acronym
- PLUS2
- Status last verified
- Oct 2023
- First submitted
- 1 Feb 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT05724082
- Acronym / sponsor ID
- PLUS2 / 2019P000649
- Conditions
- Pneumonia, Pollution; Exposure, Lung Function Decreased, Chronic Respiratory Disease, Pediatric Respiratory Diseases, Lungs; Developmental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility and acceptability of a household-based clean air intervention
Detailed description
A clean air intervention will be implemented in each household, including HEPA- based air filtration, solar lighting, and education. The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off. To determine the effect of the clean air intervention within the household, PM2.5 concentration during each cycle and lung function will be measured among household members.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.
| Arm | Type | Receives |
|---|---|---|
| Clean air intervention | Experimental | Other: Clean Air InterventionSee detailed description |
Who may qualify
- Ages
- 1 month to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age < 12 months
- Oxygen saturation < 90% or central cyanosis,
- Severe respiratory distress, or
- Signs of pneumonia with a general danger sign
- Be willing to commit to entire 2 years of follow up visits.
Key exclusion criteria (4 listed)
- Craniofacial, cardiac or other major malformation
- Neuromuscular condition that affects respiration
- Outside Smart Discharges Project catchment area
- Prior hospitalizations or known episodes of respiratory illness or episodes of pneumonia before index admission,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clean Air InterventionBased on findings from preliminary focus groups/in-depth interviews, staff will introduce various components of established clean air interventions to each household. Each household will receive interventions, depending on their known risk factors, exposures, and willingness to trial the intervention. Study staff will ask the primary cook to complete a time-activity diary during the intervention period that includes cooking episodes, duration of cooking, stove(s) used, type of food cooked, and number of people for whom the meal was cooked. Staff will continuously monitor use of the LPG/pellet stove and any other stoves owned by the household with the Berkeley Stove Use Monitoring System, a temperature logger attached to the stove to quantify the number of stove uses / time of use . Study staff will use similar loggers to monitor use of other devices installed including the air purifiers, lighting etc. | Other | Clean air intervention |
Primary outcome
Feasibility and acceptability of the clean intervention
Time frame: 2 years
Adherence with the intervention (% total up-time of the air purifier)
3 secondary outcomes
Air quality
Time frame: Up to 2 years
Pulmonary function testing
Time frame: Up to 2 years
Acceptability of using air filter device
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Moschovis, MD principal investigator
Massachusetts General Hospital
Jerome Kabakyenga, MBChB, MPH, PhD principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clean Air Intervention in people with Pneumonia and Pollution; Exposure, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the clean intervention (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.