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Can a common steroid tame deadly lung infections in the ICU?

NCT ID NCT06269900

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase III trial is testing whether adding dexamethasone, a widely used anti-inflammatory steroid, to standard care can improve outcomes for critically ill patients with severe hospital-acquired pneumonia who show signs of a strong inflammatory response. The study randomly assigns 450 participants to receive either dexamethasone or a placebo via intravenous injection, with neither patients nor doctors knowing which treatment is given. The main goals are to see if dexamethasone increases the rate of clinical cure and reduces the chance of death within 28 days, compared to placebo.

What this could mean

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

Active substance
Dexamethasone (an anti-inflammatory corticosteroid) given as an intravenous injection or infusion, compared with a placebo (inactive saltwater injection).
What this could lead to
If effective, this could establish dexamethasone as a standard add-on treatment to improve recovery and reduce death in critically ill patients with severe hospital-acquired pneumonia and an overactive inflammatory response.
What could go wrong
The trial is still in progress, and results are not yet known. Dexamethasone may not improve outcomes in this specific patient group, and corticosteroids carry risks such as increased infection or metabolic disturbances.

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 450 people

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

Started

Mar 2024

Expected to finish

Mar 2027

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 to 85 years

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: * Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body temperature \> 38°C, leukocytosis\>12000 cells per mL, leucopenia \<4000 cells per mL and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, AET, BAL, mini-BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU. Diagnosis is done at least 48 hours after hospital admission. * HAP severity defined as a PaO2/FiO2 ratio \< 300 under mechanical ventilation. * Biological systemic inflammatory response defined as CPR≥ 150 mg/L (15 mg/dL)\* * Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours. * Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible. * Person insured under a health insurance scheme. * Female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study. Exclusion Criteria: * Pregnant women (serum or urine test), breastfeeding women. * Patient under legal protection (incl. under guardianship or trusteeship). * Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients * Ongoing administration of glucocorticoid at the time of randomisation, such as for COVID-19 infection requiring supplemental oxygen therapy * Severe septic shock (norepinephrine \> 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation * Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for \>3 weeks in the past 60 days * Uncontrolled viral (hepatitis,herpes, zona, varicella) or systemic fungal infection * Immunosuppression pre-existing to hospitalisation (severe lymphopenia \< 500 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug). * Uncontrolled psychotic disorder (acute or chronical) * Patients not expected to survive for more than 48 hours. * Participation in another drug clinical trial : * testing steroids or anti-graft rejection drug or chemotherapy- radiotherapy for cancer * And / Or testing a drug regimen with a known interaction with dexamethasone, * And / Or whose implementation would alter the HAP-DEX 6-month follow-up, notably the collection of the primary outcome. * Situations that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

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Conditions

The condition(s) this trial relates to.

Healthcare-Associated Pneumonia nosocomial infection

As listed by the trial registrant

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

Hospital-acquired pneumonia

How to take part

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

  1. The places running it

    20 sites in 2 countries. 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 Angers

    RECRUITING

    Angers, France

  • CHU Beaujon

    ACTIVE_NOT_RECRUITING

    Clichy, France

  • CHU Brest

    RECRUITING

    Brest, France

  • CHU Caen

    ACTIVE_NOT_RECRUITING

    Caen, France

  • CHU Clermont - Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Limoges

    RECRUITING

    Limoges, France

  • CHU Marseille

    RECRUITING

    Marseille, France

  • CHU Nantes

    RECRUITING

    Nantes, 44000, France

  • CHU Nantes (HGRL)

    RECRUITING

    Nantes, 44000, France

  • CHU Nantes (HGRL)

    RECRUITING

    Nantes, France

  • CHU Pitié Salpétrière

    ACTIVE_NOT_RECRUITING

    Paris, France

  • CHU Poitiers

    RECRUITING

    Poitiers, France

  • CHU Raymond Poincaré

    RECRUITING

    Garches, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • Chu Amiens

    ACTIVE_NOT_RECRUITING

    Amiens, France

  • Chu Bordeaux

    RECRUITING

    Bordeaux, France

  • Chu Bordeaux

    RECRUITING

    Bordeaux, France

  • Chu Grenoble

    ACTIVE_NOT_RECRUITING

    Grenoble, France

  • Chu Montpellier

    ACTIVE_NOT_RECRUITING

    Montpellier, France

  • Chu Nancy

    ACTIVE_NOT_RECRUITING

    Nancy, France

  • Chu Nimes

    ACTIVE_NOT_RECRUITING

    Nîmes, France

  • Chu Rennes

    RECRUITING

    Rennes, France

  • Chu Strasbourg

    ACTIVE_NOT_RECRUITING

    Strasbourg, France

  • Chu Toulouse

    NOT_YET_RECRUITING

    Toulouse, France

  • Evaggelismos Hospital

    COMPLETED

    Athens, Greece

  • GHU Paris Psychiatrie et Neurosciences

    RECRUITING

    Paris, France

  • General Hospital Of LArissa

    COMPLETED

    Larissa, Greece

  • General hospital of Larisas

    COMPLETED

    Larissa, Greece

  • Hospital Clínic Barcelona

    RECRUITING

    Barcelona, Spain

  • KAT General Hospital of Athens,

    ACTIVE_NOT_RECRUITING

    Kifissia, Greece

  • Thoracic Genral Hsopital of Athens

    COMPLETED

    Athens, Greece

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