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Could a simple mouth rinse replace invasive tests for a deadly pneumonia?

NCT ID NCT02648256

Diagnosis Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a simple mouth rinse could help diagnose Pneumocystis pneumonia, a serious lung infection in people with weakened immune systems. Researchers used a PCR test on the rinse sample to look for the fungus, aiming to find a threshold that indicates active infection. The study involved 408 adults who needed a bronchoscopy for diagnosis, comparing the mouth rinse test to standard methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Polymerase Chain Reaction (PCR) on oropharyngeal rinse
What this could lead to
If successful, this could provide a simple, non-invasive way to diagnose Pneumocystis pneumonia quickly, potentially reducing the need for invasive bronchoscopy.
What could go wrong
This is a completed diagnostic study, not a treatment trial. The test may not be accurate enough to replace standard methods, and results may not apply to all patient groups.

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

408 people

The number who actually took part.

Started

Jan 2016

Finished

Aug 2024

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Age over 18 years * Clinical or radiological indication for a broncho-alveolar lavage to search infectious agents including Pneumocystis jirovecii * Patients with risk factors for developing a Pneumocystis jirovecii pneumonia : underlying malignancy (solid cancer, hematologic disease), organ transplant or hematopoietic stem cells, autoimmune disease or chronic inflammatory disease justifying immunosuppressive therapy (chemotherapy anticancer, immunomodulatory, biotherapy, corticosteroids) or patient treated with corticosteroids for more than a month or congenital immune deficiency or other causes of immunosuppression (excluding human immunodeficiency virus) at the discretion of the clinician, * Informed consent given. Exclusion Criteria: * Patient human immunodeficiency virus positive * Contraindication to the achievement of broncho-alveolar lavage, * Contraindication to the achievement of a Oropharyngeal rinse (disorder of consciousness, swallowing disorder), * Prophylaxis with cotrimoxazole or aerosol pentamidine, * Empirical curative treatment with cotrimoxazole or other curative therapeutic alternative (pentamidine, atovaquone, dapsone, clindamycin-primaquine) started for more than 48 hours, * Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.

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Conditions

The condition(s) this trial relates to.

pneumocystosis

As listed by the trial registrant

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

Pneumonia, pneumocystis

Contacts and locations

Locations

  • CHU Amiens

    Amiens, 80000, France

  • CHU Brest

    Brest, 29200, France

  • CHU Rennes

    Rennes, 35000, France

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