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Breathalyzer could replace PCR for respiratory infections

NCT ID NCT07348380

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to see if analyzing chemicals in a person's breath can rapidly detect respiratory infections like COVID-19 or the flu. Researchers will collect breath samples from 1,665 adults with symptoms and healthy volunteers. If successful, this non-invasive test could offer a faster, easier alternative to nasal swab PCR tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,665 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Eligibility Criteria \* * Inclusion Criteria \* : * Age ≥ 18 years old * Having signed a written informed consent * With clinical signs of acute respiratory infection, or with a clinical presentation of acute community-acquired pneumonia, nasopharyngitis, angina or laryngitis (except for healthy patients) * Exclusion Criteria \* : * Healthy volunteers: * Age: \< 18 years * Alcohol consumption less than 12 hours * Person with co-morbidities such as chronic respiratory failure, type II diabetes, cancerous processes, chronic liver disease, chronic kidney disease * Clinical signs of acute respiratory infection * Persons who are unable to blow into exhaled-air analysis devices (in accordance with instructions for use) * Persons under legal protection * Pregnant women, women in labor or nursing mothers * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Persons admitted to a health or social institution for purposes other than research * Adults under legal protection (guardianship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme * Patients with respiratory symptoms * Age: \< 18 years * Patients whose symptoms have been present for more than 7 days * Persons unable to blow into the device for breath analysis (in accordance with the operating instructions) * Patients suffering from cystic fibrosis * Patients with severe chronic respiratory insufficiency requiring long-term oxygen therapy or NIV (non-invasive ventilation), excluding CPAP (Continuous Positive Airway Pressure) for sleep apnea * Patients under legal protection * Pregnant women, women in labor or nursing mothers * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Persons admitted to a health or social institution for purposes other than research * Adults under legal protection (guardianship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emergency department (Hôpital de la Croix-Rousse, Hospices Civils de Lyon) Lyon (France) 69004

    Lyon, 69004, France

  • Maison de Santé Pluriprofessionnelle Universitaire (Hôpital de la Croix-Rousse, Hospices Civils de Lyon)

    Lyon, 69004, France

  • National reference center for respiratory viruses (Hôpital de la Croix-Rousse, Hospices Civils de Lyon)

    Lyon, 69004, France