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Can viruses that eat bacteria beat a deadly hospital lung infection?

NCT ID NCT07804082

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether inhaling bacteriophages, which are viruses that specifically kill Pseudomonas aeruginosa bacteria, can help clear a serious lung infection in patients on breathing machines. The study includes adults with ventilator-associated pneumonia caused by this bacteria, who will receive either the phage treatment or a placebo, in addition to standard antibiotics. The goal is to see if the phages improve survival and cure rates without the infection coming back.

What this could mean

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

Active substance
Nebulized bacteriophages (viruses that target and kill Pseudomonas aeruginosa bacteria)
What this could lead to
If it works, this could offer a new way to treat ventilator-associated pneumonia caused by Pseudomonas, especially when antibiotics fail.
What could go wrong
The trial is still testing the approach, and phage therapy may not work in all patients. There is also a risk of side effects from inhaling the phages.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 184 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

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: 1. Patients ≥ 18 years old 2. Intubated and mechanically ventilated for at least 48 hours 3. Mechanical ventilation expected to continue for at least 3 days 4. Clinical diagnosis of VAP 5. VAP due to P. aeruginosa (P. aeruginosa recovered at a significant level from lung sample (≥10\^4/ml for BAL or ≥10\^5/ml for tracheal aspirate or ≥10\^3 CFU/ml for plugged telescopic catheter) 6. Signed informed consent from the patient or the patient's legal representative or a family member or a close relative. According to the legal conditions of emergency inclusion, randomization without the family member or the surrogate consent could be performed if the patient is unable to give his/her consent and if no legal representative/family member or close relative is present. Close relative/ legal representative/family member consent will be asked as soon as possible. The patient will be asked to give his/her consent for continuation of the trial when his/her condition will allow. 7. Patient with childbearing potential\* should have reliable contraception for the all duration of the study 8. Affiliation to social security (AME excluded) Exclusion Criteria: 1. Severe hypoxemia as defined by PaO2/FiO2 \< 100 mmHg, except if the patient is on ECMO (extracorporeal membrane oxygenation) 2. Impossibility to set a tidal volume of 6 ml/kg of ideal body weight during nebulization without risk of barotrauma 3. Patients with cystic fibrosis, lung cancer, lung resection, known bronchial obstruction, or active tuberculosis 4. Patient not expecting to survive 48 hours after randomization 5. Polymicrobial VAP (presence of pathogens other than P. aeruginosa at a significant level in lung samples (≥10\^4/ml for BAL or ≥10\^5/ml for tracheal aspirate). If the culture retrieves oropharyngeal flora, even at a significant threshold, in addition to Pseudomonas aeruginosa, the patient is eligible. 6. Contraindication to nebulization 7. Participation in another interventional study evaluating drugs for VAP or being in the exclusion period following the end of a previous interventional study evaluating drugs for VAP 8. Pregnancy or breastfeeding 9. Patients under guardianship or curatorship

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Conditions

The condition(s) this trial relates to.

pneumonia caused by pseudomonas aeruginosa infection Pseudomonas aeruginosa infectious disease Pseudomonas infection

As listed by the trial registrant

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

Pseudomonas aeruginosa infection Ventilator associated bacterial pneumonia

How to take part

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

  1. The places running it

    16 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

  • CHU Amiens

    Amiens, 80054, France

  • CHU Amiens

    Amiens, 80054, France

  • CHU Angers

    Angers, 49933, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Nice

    Nice, 06200, France

  • CHU Orléans

    Orléans, 45000, France

  • Hôpital Avicenne

    Bobigny, 93000, France

  • Hôpital Avicenne

    Bobigny, 93000, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Henri Mondor

    Créteil, 94000, France

  • Hôpital Louis Mourier

    Colombes, 92700, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

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