Hospital Acquired PneumoniaPhase 3HAP-DEXNCT06269900
Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
A Phase 3 study testing Dexamethasone in people with Hospital Acquired Pneumonia, run by Nantes University Hospital at 34 sites in 3 countries.
Trial summary
Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hospital Acquired Pneumonia
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 26 Mar 2024to 15 Mar 2027
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
34 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 3 countries
France28 sites, 19 recruiting
- Active, not recruiting
Chu Amiens
Amiens
- Recruiting
CHU Angers
Angers
Sigismond LASOCKI, SiLasocki@chu-angers.fr
- Recruiting
Chu Bordeaux
Bordeaux
Hugues DE COURSON, 0033557821019, hugues.de-courson@chu-bordeaux.fr
- Recruiting
Chu Bordeaux
Bordeaux
MATTHIEU BIAIS, 0033557821019, matthieu.biais@chu-bordeaux.fr
- Recruiting
CHU Brest
Brest
Etienne BOTQUELEN, 0033298145006, etienne.BOTQUELEN@chu-brest.fr
- Active, not recruiting
CHU Caen
Caen
- Recruiting
CHU Clermont - Ferrand
Clermont-Ferrand
Russell CHABANNE, rchabanne@chu-clermontferrand.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lucie AUPETITGENDRE, laupetitgendre@chu-clermontferrand.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Pierre COUHAULT, couhault@chu-clermontferrand.fr
- Active, not recruiting
CHU Beaujon
Clichy
- Recruiting
CHU Raymond Poincaré
Garches
Djillali ANNANE, 0033147107787, djillali.annane@aphp.fr
- Active, not recruiting
Chu Grenoble
Grenoble
- Recruiting
CHU Limoges
Limoges
Bruno FRANCOIS, bruno.francois@chu-limoges.fr
- Recruiting
CHU Marseille
Marseille
Marc LEONE, marc.leone@ap-hm.fr
- Active, not recruiting
Chu Montpellier
Montpellier
- Active, not recruiting
Chu Nancy
Nancy
- Recruiting
CHU Nantes (HGRL)
Nantes, 44000
Karim LAKHAL, karim.lakhal@chu-nantes.fr
- Recruiting
CHU Nantes
Nantes, 44000
Antoine ROQUILLY, +33253482835, antoine.roquilly@chu-nantes.fr
- Recruiting
CHU Nantes (HGRL)
Nantes
Mickael VOURC'H, mickael.vourch@chu-nantes.fr
- Active, not recruiting
Chu Nimes
Nîmes
- Active, not recruiting
CHU Pitié Salpétrière
Paris
- Recruiting
GHU Paris Psychiatrie et Neurosciences
Paris
Aurélien MAZERAUD, a.mazeraud@ghu-paris.fr
- Recruiting
CHU Poitiers
Poitiers
Claire DAHYOT FIZELIER, claire.dahyot-fizelier@chu-poitiers.fr
- Recruiting
CHU Rennes
Rennes
Yoann LAUNEY, yoann.launey@chu-rennes.fr
- Recruiting
CHU Rennes
Rennes
Jean-Marc TADIE, jeanmarc.tadie@chu-rennes.fr
- Recruiting
Chu Rennes
Rennes
Nicolas NESSELER, nicolas.nesseler@chu-rennes.fr
- Active, not recruiting
Chu Strasbourg
Strasbourg
- Not yet recruiting
Chu Toulouse
Toulouse
Fanny BOUNES, 0033 5 61 32 27 99, bounes.f@chu-toulouse.fr
Greece5 sites
- Completed
Evaggelismos Hospital
Athens
- Completed
Thoracic Genral Hsopital of Athens
Athens
- Active, not recruiting
KAT General Hospital of Athens,
Kifissia
- Completed
General hospital of Larisas
Larissa
- Completed
General Hospital Of LArissa
Larissa
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic Barcelona
Barcelona
Carlos Ferrando Ortolá
About this study
Official title: Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, an International Phase III, Double-blind, Placebo-controlled, Randomized Trial
Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.
- Conditions
- Hospital Acquired Pneumonia
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone phosphate injection is given as a slow injection or infusion (intravenous drip) into the veins.
PlaceboDrug
Placebo injection is given as a slow injection or infusion (intravenous drip) into the veins.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone + standard of care | Experimental | * Dexamethasone 0.2mg.kg-1.day-1 intravenous for a minimal duration of 5 days, and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio < 300).
* Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days. Receives: Drug: Dexamethasone |
| Placebo + Standard of care | Placebo comparator | * Placebo 0.2mg.kg-1.day-1 intravenous for 5 days and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio < 300).
* Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate at the test-of-cure visit (TOC visit)
It's a hierarchic procedure. First, we will test the dexamethasone superiority on the clinical cure rate at the test-of-cure visit realized 8 days (acceptable time frame Day 8-10) after randomization or at the ICU discharge (if it occurs before).
Measured: Day 8-10
The rate of all-cause mortality on Day 28.
Measured: Day 28
Secondary outcomes (14)
Rate of death
All-cause mortality
Measured: Month 3 , Month 6
Rate of pleural empyema at Day 28.
Measured: Day 28
Rate of microbiological failure
Measured: Toc 1 day visit
Rate of pneumonia relapse
Measured: day 28
Duration of hospitalization and hospital-free days
Measured: Month 6
Rates of non-respiratory hospital-acquired infection
Measured: Day 28
Antibiotic-free days at Day 28
Measured: Day 28
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days
Measured: Month 6
Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event)
- Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR)
- Rate of metabolic adverse events
Measured: day 28
Rate of gastric ulcer
Measured: day 28
Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale
Changes in anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale ) scale in order to assess the acceptability of dexamethasone from the patients' perspectives
Measured: month 3, month 6
Changes in subjective well-being with the Satisfaction With Life Scale (SWLS)
Changes in subjective well-being from M3 to M6 measured with the Satisfaction With Life Scale (SWLS) in order to assess the acceptability of dexamethasone from the patients' perspectives
Measured: month 3, month 6
Changes in health-related quality of life measured with the Short Form (SF)-36
Changes in health-related quality of life with the Short Form (SF)-36 scale in order to assess the acceptability of dexamethasone from the patients' perspectives:
Measured: month 3, month 6
the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER)
We will assess the economic efficiency of dexamethasone plus standard of care compared to standard of care by performing a cost-effectiveness analysis (CEA) using QALYs (Quality-Adjusted Life-Years) as a measure of health outcomes. the CEA will estimate an incremental cost effectiveness ratio (ICER) using a collective perspective; The ICER will be expressed in terms of costs per QALY gained.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start26 Mar 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ROQUILLY, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269900
- Sponsor's protocol ID
- RC23_0358
- Acronym
- HAP-DEX
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, an International Phase III, Double-blind, Placebo-controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT06269900
- Acronym / sponsor ID
- HAP-DEX / RC23_0358
- Conditions
- Hospital Acquired Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 21 Feb 2024 (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.
Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone + standard of care | Experimental | Drug: Dexamethasone* Dexamethasone 0.2mg.kg-1.day-1 intravenous for a minimal duration of 5 days, and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio < 300). * Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days. |
| Placebo + Standard of care | Placebo comparator | Drug: Placebo* Placebo 0.2mg.kg-1.day-1 intravenous for 5 days and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio < 300). * Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| DexamethasoneDexamethasone phosphate injection is given as a slow injection or infusion (intravenous drip) into the veins. | Drug | dexamethasone + standard of care |
| PlaceboPlacebo injection is given as a slow injection or infusion (intravenous drip) into the veins. | Drug | Placebo + Standard of care |
Primary outcome
Clinical cure rate at the test-of-cure visit (TOC visit)
Time frame: Day 8-10
It's a hierarchic procedure. First, we will test the dexamethasone superiority on the clinical cure rate at the test-of-cure visit realized 8 days (acceptable time frame Day 8-10) after randomization or at the ICU discharge (if it occurs before).
The rate of all-cause mortality on Day 28.
Time frame: Day 28
14 secondary outcomes
Rate of death
Time frame: Month 3 , Month 6
Rate of pleural empyema at Day 28.
Time frame: Day 28
Rate of microbiological failure
Time frame: Toc 1 day visit
Rate of pneumonia relapse
Time frame: day 28
Duration of hospitalization and hospital-free days
Time frame: Month 6
Rates of non-respiratory hospital-acquired infection
Time frame: Day 28
Antibiotic-free days at Day 28
Time frame: Day 28
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days
Time frame: Month 6
Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event)
Time frame: day 28
Rate of gastric ulcer
Time frame: day 28
Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale
Time frame: month 3, month 6
Changes in subjective well-being with the Satisfaction With Life Scale (SWLS)
Time frame: month 3, month 6
Changes in health-related quality of life measured with the Short Form (SF)-36
Time frame: month 3, month 6
the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER)
Time frame: month 6
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Antoine ROQUILLY principal investigator
Nantes University Hospital
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Hospital Acquired Pneumonia, run by Nantes University Hospital at 34 sites in 3 countries.
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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Greece, Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Antoine ROQUILLY (+33253482876, antoine.roquilly@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate at the test-of-cure visit (TOC visit) (time frame: Day 8-10). The study lists 2 primary outcomes in all. 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 19 Aug 2026.