Acute Respiratory Tract InfectionHAIQUNCT07670117
HAIQU (Hospital AIr QUality)
A study testing Self-swab test in people with Acute Respiratory Tract Infection, run by Mayo Clinic at 3 sites in United States.
Trial summary
The purpose of this research is to assess whether integration of an aerosol biosensor and air quality risk assessment software that integrates into a building management system will improve indoor air quality metrics in hospital environments and reduces risk factors associated with respiratory disease transmission. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- Self-swab test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Target Group:
- Mayo Clinic Staff working in ED with a minimum of .7 FTE in Midwest (MN and WI), Phoenix (AZ), or Jacksonville (FL) and patient contact.
- Reference Group:
- Mayo Clinic Staff working in primary care with a minimum of .7 FTE. in Rochester (MN), Phoenix (AZ), or Jacksonville (FL) and patient contact
Who cannot join
- Any participant who does not meet either of the inclusion criteria.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: HAIQU (Hospital AIr QUality): Breathing Life Into Patient Care
The purpose of this research is to assess whether integration of an aerosol biosensor and air quality risk assessment software that integrates into a building management system will improve indoor air quality metrics in hospital environments and reduces risk factors associated with respiratory disease transmission.
Read the detailed description
Executive Summary. The Hospital AIr QUality (HAIQU) team will develop a biosensor and risk assessment software to detect pathogens in indoor air, to be integrated with building management system (BMS), focusing on improving indoor air quality in hospitals to reduce disease transmission and enhance patient outcomes. The HAIQU biosensor will combine high-flow-rate aerosol collection highly sensitive and specific CRISPR detection, and digital droplet microfluidics to continuously detect multiple viral, bacterial, and fungal pathogens from indoor air. The HAIQU risk assessment software will combine multi-scale modeling into a 'digital twin', or virtual representation of an indoor space to model pathogen distribution and exposure risk to occupants. The HAIQU tools will be applied in clinical studies within the emergency departments (EDs) of Mayo Clinic campuses in MN, WI, AZ, and FL. Integrating with building control systems, the HAIQU biosensor and software will inform strategies to mitigate bioaerosol risks, enhance productivity, save energy and costs, and protect the health of staff and patients. By ensuring clean and safe indoor air, these tools will contribute to smarter, more resilient buildings that improve cognitive performance, wellness, and overall human health.
Goals and Impact. Although people spend the majority of our time indoors, indoor air quality (IAQ) is often overlooked, with more attention given to outdoor air quality. However, clean indoor air is essential for health and well-being. Monitoring of indoor air currently lags behind other 'big data' surveillance technologies, such as wearable health monitors and disease tracking. HAIQU aims to bridge this gap by developing rapid, real-time biosensing and risk assessment tools for healthier and safer hospital buildings. Current biosensing methods are slow, non-autonomous, and limited to detecting only a few pathogens at a time. Typically, aerosol samples are collected onto a filter over two to eight hours, then manually processed for detection, often using nucleic acid amplification. For example, researchers at Mayo performed clinical trials using the Thermo Scientific AerosolSense paired with the Renvo Rapid PCR Test to detect influenza A/B, SARS-CoV-2, and RSV. Though advanced microfluidic nucleic acid amplification methods exist that are more conductive to multiplexing, combining these methods with continuous or semi-continuous aerosol collection for rapid, autonomous detection is still lacking. To detect bioaerosols which are present at very low concentrations (<1 per L), high flow rate sampling must be paired with highly sensitive, multiplexed detection methods. Here, the investigators propose the HAIQU biosensor, a portable device that enables rapid, autonomous, and near real-time bioaerosol detection. It combines high flow rate virtual impactors and condensers for aerosol capture with drop-based microfluidics, CRISPR-Cas-based detection, and multiplexed barcoding. The healthcare environment provides an ideal use case for the proposed technologies. In EDs, patients often present with undiagnosed infectious diseases that can lead to significant exposures and outbreaks among staff, patients, and visitors, sometimes only recognized after diagnosis. Detection of airborne pathogens can prevent and reduce hospital-acquired infections, which are a leading cause of illness and lost worktime.
TECHNICAL AREA 1: The final HAIQU biosensor will be capable of detecting multiple pathogens (25 real-world, viral + bacterial + fungi; 100 lab-based) with >95% sensitivity and >99% specificity, once every 45 minutes.
TECHNICAL AREA 2: HAIQU risk assessment software will include a multiscale modeling framework to predict and assess infectious disease risk in indoor environments. The multi-scale modeling framework incorporates scales from individual events to room-level and system-level information, to yield outputs and predictions of bioaerosol dispersion, infection risk, number infected, intervention recommendations, and energy calculations.
TECHNICAL AREA 3: Multi-site field trials using the HAIQU biosensor and software in Mayo Clinic's emergency departments will be performed targeting a 25% decrease in facility-related incidence of each targeted respiratory illness relative to baseline data. Biosensor data will be combined with air quality sensing data and multi-system building controls and intervention.
- Conditions
- Acute Respiratory Tract Infection
- Being tested
- Self-swab test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-swab testDiagnostic test
Participants will self-report when they are experiencing respiratory symptoms and will be asked for a self-swab to be used for data analysis.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department Employees | Experimental | Emergency Department employees will act as the target group with the Emergency Department building implementing the HAIQU air quality sensor. Receives: Diagnostic Test: Self-swab test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants to experience acute respiratory infection (ARI) symptoms
Symptoms include: at least 2 upper respiratory symptoms for at least 24 hours; OR at least 2 symptoms that include an upper/lower respiratory symptom and a systemic symptom (fever, fatigue, body aches, headache, decreased appetite) for at least 24 hours
Measured: 3 years
Secondary outcomes (2)
Number of confirmed cases of acute respiratory infections
Number of cases confirmed by at least one viral panel-positive swab detected by RT-PCR
Measured: 3 years
Number of confirmed cases of lower respiratory tract disease
Number of cases of lower respiratory tract disease confirmed by at least one viral panel-positive swab detected by RT-PCR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single group
- Model description
- This study will use a prospective cohort study design (single arm) to evaluate the association between the incidence of acute respiratory infections (ARI) and pathogens in indoor air quality detected through either manual biosampling or the HAIQU biosensor. The investigators will estimate the incidence of ARI in approximately 600 (minimum: 300) adults (\>=18 years) working in Emergency Department of Mayo Clinic (Midwest (MN, WI), FL, and AZ). After completion of subject recruitment (Year 1) for this Target group, ARI in Year 2 will serve as baseline (pre-intervention for the building) data, followed by Year 3 for supporting development and optimization of building intervention and Year 4 for post-intervention data. To account for secular trends that affect ARI incidence independent of the intervention (e.g. changes in infection patterns, medical practice, testing methods), the investigators will recruit an additional 250 adults (min 150) working in primary care settings (MN, FL, AZ).
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Research Projects Agency for Health (ARPA-H), Roche Pharma AG
- Responsible party
- Principal investigator, Connie B. Chang, Mayo Clinic
- Investigators
- Connie Chang, Ph.D., Principal investigator, Mayo ClinicChung Wi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670117
- Sponsor's protocol ID
- 24-013166
- Other IDs
- ARPA-H-SOL-24-107
- Acronym
- HAIQU
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study collects detailed longitudinal health, occupational, and location-related information from Mayo Clinic employees. Although data will be coded for research purposes, the combination of respiratory health outcomes, workplace characteristics, and real-time location system (RTLS) data may increase the risk of participant re-identification. To protect participant privacy, confidentiality, and institutional data security requirements, individual-level datasets will not be made available to external researchers. Aggregate and de-identified study results will be reported through scientific publications and presentations in accordance with applicable regulations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAIQU (Hospital AIr QUality): Breathing Life Into Patient Care
- ClinicalTrials.gov ID
- NCT07670117
- Acronym / sponsor ID
- HAIQU / 24-013166
- Conditions
- Acute Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Advanced Research Projects Agency for Health (ARPA-H), Roche Pharma AG
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 26 Jun 2026 (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.
The purpose of this research is to assess whether integration of an aerosol biosensor and air quality risk assessment software that integrates into a building management system will improve indoor air quality metrics in hospital environments and reduces risk factors associated with respiratory disease transmission.
Detailed description
Executive Summary. The Hospital AIr QUality (HAIQU) team will develop a biosensor and risk assessment software to detect pathogens in indoor air, to be integrated with building management system (BMS), focusing on improving indoor air quality in hospitals to reduce disease transmission and enhance patient outcomes. The HAIQU biosensor will combine high-flow-rate aerosol collection highly sensitive and specific CRISPR detection, and digital droplet microfluidics to continuously detect multiple viral, bacterial, and fungal pathogens from indoor air. The HAIQU risk assessment software will combine multi-scale modeling into a 'digital twin', or virtual representation of an indoor space to model pathogen distribution and exposure risk to occupants. The HAIQU tools will be applied in clinical studies within the emergency departments (EDs) of Mayo Clinic campuses in MN, WI, AZ, and FL. Integrating with building control systems, the HAIQU biosensor and software will inform strategies to mitigate bioaerosol risks, enhance productivity, save energy and costs, and protect the health of staff and patients. By ensuring clean and safe indoor air, these tools will contribute to smarter, more resilient buildings that improve cognitive performance, wellness, and overall human health.
Goals and Impact. Although people spend the majority of our time indoors, indoor air quality (IAQ) is often overlooked, with more attention given to outdoor air quality. However, clean indoor air is essential for health and well-being. Monitoring of indoor air currently lags behind other 'big data' surveillance technologies, such as wearable health monitors and disease tracking. HAIQU aims to bridge this gap by developing rapid, real-time biosensing and risk assessment tools for healthier and safer hospital buildings. Current biosensing methods are slow, non-autonomous, and limited to detecting only a few pathogens at a time. Typically, aerosol samples are collected onto a filter over two to eight hours, then manually processed for detection, often using nucleic acid amplification. For example, researchers at Mayo performed clinical trials using the Thermo Scientific AerosolSense paired with the Renvo Rapid PCR Test to detect influenza A/B, SARS-CoV-2, and RSV. Though advanced microfluidic nucleic acid amplification methods exist that are more conductive to multiplexing, combining these methods with continuous or semi-continuous aerosol collection for rapid, autonomous detection is still lacking. To detect bioaerosols which are present at very low concentrations (<1 per L), high flow rate sampling must be paired with highly sensitive, multiplexed detection methods. Here, the investigators propose the HAIQU biosensor, a portable device that enables rapid, autonomous, and near real-time bioaerosol detection. It combines high flow rate virtual impactors and condensers for aerosol capture with drop-based microfluidics, CRISPR-Cas-based detection, and multiplexed barcoding. The healthcare environment provides an ideal use case for the proposed technologies. In EDs, patients often present with undiagnosed infectious diseases that can lead to significant exposures and outbreaks among staff, patients, and visitors, sometimes only recognized after diagnosis. Detection of airborne pathogens can prevent and reduce hospital-acquired infections, which are a leading cause of illness and lost worktime.
TECHNICAL AREA 1: The final HAIQU biosensor will be capable of detecting multiple pathogens (25 real-world, viral + bacterial + fungi; 100 lab-based) with >95% sensitivity and >99% specificity, once every 45 minutes.
TECHNICAL AREA 2: HAIQU risk assessment software will include a multiscale modeling framework to predict and assess infectious disease risk in indoor environments. The multi-scale modeling framework incorporates scales from individual events to room-level and system-level information, to yield outputs and predictions of bioaerosol dispersion, infection risk, number infected, intervention recommendations, and energy calculations.
TECHNICAL AREA 3: Multi-site field trials using the HAIQU biosensor and software in Mayo Clinic's emergency departments will be performed targeting a 25% decrease in facility-related incidence of each targeted respiratory illness relative to baseline data. Biosensor data will be combined with air quality sensing data and multi-system building controls and intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use a prospective cohort study design (single arm) to evaluate the association between the incidence of acute respiratory infections (ARI) and pathogens in indoor air quality detected through either manual biosampling or the HAIQU biosensor. The investigators will estimate the incidence of ARI in approximately 600 (minimum: 300) adults (>=18 years) working in Emergency Department of Mayo Clinic (Midwest (MN, WI), FL, and AZ). After completion of subject recruitment (Year 1) for this Target group, ARI in Year 2 will serve as baseline (pre-intervention for the building) data, followed by Year 3 for supporting development and optimization of building intervention and Year 4 for post-intervention data. To account for secular trends that affect ARI incidence independent of the intervention (e.g. changes in infection patterns, medical practice, testing methods), the investigators will recruit an additional 250 adults (min 150) working in primary care settings (MN, FL, AZ).
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Employees | Experimental | Diagnostic Test: Self-swab testEmergency Department employees will act as the target group with the Emergency Department building implementing the HAIQU air quality sensor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mayo Clinic Staff working in ED with a minimum of .7 FTE in Midwest (MN and WI), Phoenix (AZ), or Jacksonville (FL) and patient contact.
- Mayo Clinic Staff working in primary care with a minimum of .7 FTE. in Rochester (MN), Phoenix (AZ), or Jacksonville (FL) and patient contact
Key exclusion criteria (1 listed)
- Any participant who does not meet either of the inclusion criteria.
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 |
|---|---|---|
| Self-swab testParticipants will self-report when they are experiencing respiratory symptoms and will be asked for a self-swab to be used for data analysis. | Diagnostic test | Emergency Department Employees |
Primary outcome
Number of participants to experience acute respiratory infection (ARI) symptoms
Time frame: 3 years
Symptoms include: at least 2 upper respiratory symptoms for at least 24 hours; OR at least 2 symptoms that include an upper/lower respiratory symptom and a systemic symptom (fever, fatigue, body aches, headache, decreased appetite) for at least 24 hours
2 secondary outcomes
Number of confirmed cases of acute respiratory infections
Time frame: 3 years
Number of confirmed cases of lower respiratory tract disease
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study collects detailed longitudinal health, occupational, and location-related information from Mayo Clinic employees. Although data will be coded for research purposes, the combination of respiratory health outcomes, workplace characteristics, and real-time location system (RTLS) data may increase the risk of participant re-identification. To protect participant privacy, confidentiality, and institutional data security requirements, individual-level datasets will not be made available to external researchers. Aggregate and de-identified study results will be reported through scientific publications and presentations in accordance with applicable regulations and institutional policies.
Related trials for Acute Respiratory Tract Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Recruiting
Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds
Acute Otitis Media (AOM), Upper Respiratory Infection
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
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.
Connie Chang, Ph.D. principal investigator
Mayo Clinic
Chung Wi, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-swab test in people with Acute Respiratory Tract Infection, run by Mayo Clinic at 3 sites 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAIQU Research Staff (507-422-3077, BreatheResearch@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants to experience acute respiratory infection (ARI) symptoms (time frame: 3 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 29 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.