AsthmaNCT03647397
PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
A study testing Photo Electrochemical Oxidation (PECO) for Air Purification in people with Asthma and Pneumonia, run by Molekule at 1 site in United States.
Trial summary
This study will investigate the efficacy of a novel air purification technology, Photo Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory distress. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Asthma, Pneumonia, Respiratory Distress Syndrome
- What is being tested?
- Photo Electrochemical Oxidation (PECO) for Air Purification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 31 Dec 2018
- 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 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Any patient admitted to the NICU
- Patients in the ER only
- Any patient with non-respiratory conditions
- Adults
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercyhealth Hospital - Rockton Avenue
Rockford, Illinois, 61103
About this study
Official title: Use of PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
This study will investigate the efficacy of a novel air purification technology, Photo Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory distress. The study will take place at Mercyhealth Hospital - Rockton Avenue where all 23 pediatric rooms will be outfitted with portable PECO air purifying units. The main outcomes are the length of stay and progression to ICU, which will be compared with historical controls.
Read the detailed description
The goal of this study is to assess whether using PECO to purify air in a hospital can improve health outcomes for pediatric patients with respiratory distress.
The results of this study will be used in three primary ways:
- As evidence to support an installation of PECO in hospital HVAC systems to improve the standard of care for patients with respiratory distress
- Towards dissemination efforts through publication in a peer-reviewed journal and presentation at national and international conferences
- For informing healthcare providers and stakeholders
There are no plans to repeat this study with other hospital partners
- Conditions
- Asthma, Pneumonia, Respiratory Distress Syndrome
- Being tested
- Photo Electrochemical Oxidation (PECO) for Air Purification
- Keywords
- asthma, environmental intervention, respiratory distress, pediatric hospitalization, pneumonia, bronchiolitis
- Medical subject headings
- Asthma, Pneumonia, Respiratory Distress Syndrome, Dyspnea, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo Electrochemical Oxidation (PECO) for Air PurificationDevice
PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.
| Study group | Role | What they receive |
|---|---|---|
| PECO | Experimental | All pediatric patients admitted for respiratory distress will have the intervention of Photo Electrochemical Oxidation (PECO) for Air Purification. Receives: Device: Photo Electrochemical Oxidation (PECO) for Air Purification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Total length of hospital stay for patient
Measured: 5 months
Secondary outcomes (1)
Readmission rate
Rate of readmission within 30 days of discharge
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start8 Aug 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molekule
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mercy Health System
- Responsible party
- Sponsor
- Investigators
- Nikhil Rao, Principal investigator, Molekule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647397
- Sponsor's protocol ID
- Molekule-08082018
- Status last verified
- May 2019
- First submitted
- 20 Aug 2018
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
- ClinicalTrials.gov ID
- NCT03647397
- Acronym / sponsor ID
- Molekule-08082018
- Conditions
- Asthma, Pneumonia, Respiratory Distress Syndrome
- Keywords
- asthma, environmental intervention, respiratory distress, pediatric hospitalization, pneumonia, bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- MolekuleIndustry (pharma, biotech, devices)
- Collaborators
- Mercy Health System
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Aug 2018 (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 investigate the efficacy of a novel air purification technology, Photo Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory distress. The study will take place at Mercyhealth Hospital - Rockton Avenue where all 23 pediatric rooms will be outfitted with portable PECO air purifying units. The main outcomes are the length of stay and progression to ICU, which will be compared with historical controls.
Detailed description
The goal of this study is to assess whether using PECO to purify air in a hospital can improve health outcomes for pediatric patients with respiratory distress.
The results of this study will be used in three primary ways:
- As evidence to support an installation of PECO in hospital HVAC systems to improve the standard of care for patients with respiratory distress
- Towards dissemination efforts through publication in a peer-reviewed journal and presentation at national and international conferences
- For informing healthcare providers and stakeholders
There are no plans to repeat this study with other hospital partners
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PECO | Experimental | Device: Photo Electrochemical Oxidation (PECO) for Air PurificationAll pediatric patients admitted for respiratory distress will have the intervention of Photo Electrochemical Oxidation (PECO) for Air Purification. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Any patient admitted to the NICU
- Patients in the ER only
- Any patient with non-respiratory conditions
- Adults
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 |
|---|---|---|
| Photo Electrochemical Oxidation (PECO) for Air PurificationPECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress. | Device | PECO |
Primary outcome
Length of stay
Time frame: 5 months
Total length of hospital stay for patient
1 secondary outcome
Readmission rate
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- 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.
Nikhil Rao principal investigator
Molekule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo Electrochemical Oxidation (PECO) for Air Purification in people with Asthma and Pneumonia, run by Molekule at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 17 May 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of stay (time frame: 5 months). 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 17 May 2019.