Community Acquired PneumoniaPhase 3CAPE_CODNCT02517489
Community-Acquired Pneumonia : Evaluation of Corticosteroids
A Phase 3 study testing Hydrocortisone in people with Community Acquired Pneumonia, run by University Hospital, Tours at 32 sites in France.
Trial summary
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 952 participants
- Where
- 32 sitesFrance
- Study dates
- 28 Oct 2015to 28 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients affiliated to social security scheme
- Admission to an Intensive Care Unit (ICU) or intermediate care unit participating to the trial
- Diagnosis of Community- Acquired Pneumonia (CAP) suggested by at least two of the following: cough, purulent sputum, chest pain and dyspnea
- Focal shadowing/infiltrate on chest X-ray or CT-scan
- Diagnosis of Community- Acquired Pneumonia (CAP) during the 48 hours post-hospital admission
Show all 19Show fewer
- Study drug infusion initiated no longer than 24 hours post first severity criterion
- Severity defined by at least one of the following:
- Pneumonia Severity Index (PSI) > 130 (Fine class V)
- Patient placed on mechanical ventilation (invasive or not) for acute respiratory failure, with a PEEP level of 5 cm of water or more
- Patient treated by high-flow oxygen therapy with a FiO2 of 50% or more and a P/F ratio less than 300
- Patient treated by oxygen therapy with a partial rebreathing-mask with a reservoir bag, provided that the PaO2 is less than (cf. table):
- Oxygen flow (L/min) 6 7 8 9 10 or more PaO2 (mmHg) less than 180 210 240 270 300
- Patient already treated by antibiotics (at least one dose since admission to hospital)
- Informed consent signed by the patient, its relatives or emergency procedure
- On the sub-group of patients included with COVID19 :
- Diagnosis of COVID19 either as certain (PCR) or probable (evocative clinical and radiological features AND epidemic context AND absence of other microbiological documentation).
- Study drug infusion initiated no longer than 24 hours post first severity criterion ; in case of transfer from another hospital, this period will be prolonged to 48 hours
- Patient receiving the best available treatment as define by up-to-date scientific knowledge
Who cannot join
- Patient treated by vasopressors for septic shock at the time of inclusion
- Clinical history suggesting of aspiration of gastric content
- Patient treated by invasive mechanical ventilation within 14 days before current hospital admission
- Patient treated by antibiotics for a respiratory infection for more than seven days at the admission to the hospital (except if a pathogen resistant to this antibiotics is isolated)
- History of cystic fibrosis
- Post-obstructive pneumonia
Show all 17Show fewer
- Patients in which rapid PCR-test is positive for flu
- Active tuberculosis or fungal infection
- Active viral hepatitis or active infection with herpes viruses
- Myelosuppression
- Decision of withholding mechanical ventilation or endotracheal intubation
- Hypersensitivity to corticosteroids
- Patient needing anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason
- Patients under treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days
- Patient already enrolled in another drug trial with mortality as an end-point. If the patient is already participating in another therapeutic trial with a different endpoint, the investigator must verify that inclusion in CAPE COD can not prejudice it.
- Pregnant or breastfeeding woman
- Patient on judicial protection
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
Service de Réanimation - Unité de Soins Continus, CH d'Angoulême
Angoulême, 16959
Service de Réanimation Polyvalente, CH d'Argenteuil
Argenteuil, 95107
Service de Réanimation, CHR Metz-Thionville
Ars-Laquenexy, 57530
Service de Réanimation
Aulnay-sous-Bois, 93602
Service de Réanimation
Belfort, 90015
Service de Réanimation
Bourg-en-Bresse
Service de Réanimation HIA Clermont-Tonnerre
Brest, 29240
Service de Réanimation Médicale, CHU de Brest
Brest, 29609
Service de Réanimation, CHU Côte de Nacre
Caen, 14033
Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres
Chartres, 28000
Service de Réanimation Médicale Polyvalente, Hôpital G Montpied
Clermont-Ferrand, 63003
Service de Réanimation, Hôpital Louis Mourier
Colombes, 92700
Service de Réanimation Médicale, CHU de Dijon
Dijon, 21079
Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP
Garches, 92380
Service de Réanimation Médicale, CHU de Grenoble
Grenoble, 38043
Service de Réanimation Polyvalente, CHD La Roche sur Yon
La Roche-sur-Yon, 85925
Service de Réanimation, CH Le Mans
Le Mans, 72037
Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille
Lille, 59037
Service de Réanimation Polyvalente, CHU de Limoges
Limoges, 87042
Service de Réanimation Médicale, Hôpital Nord
Marseille, 13015
Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban
Montauban, 82013
Service de Réanimation Médicale, CHU de Nancy
Nancy, 54511
Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes
Nantes, 44093
Service de Réanimation Médicale, CHR d'Orléans
Orléans, 45067
Service de Réanimation Médicale, Hôpital Cochin, APHP
Paris, 75014
Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP
Paris, 75020
Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers
Poitiers, 86021
Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes
Rennes, 35033
Service de Réanimation
Saint-Brieuc, 22000
Service de Réanimation Polyvalente, CH de Saint Malo
St-Malo, 35403
Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg
Strasbourg, 67091
Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg
Strasbourg, 67098
About this study
Official title: Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.
A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia.
Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.
Read the detailed description
Patients will receive state-of-the-art standard therapy for severe Community-Acquired Pneumonia (CAP), including antibiotics and supportive care. Correction of hypoxemia will use standard low-flow oxygen therapy, high-flow oxygen therapy, non-invasive-ventilation or invasive ventilation with endotracheal tube, as required. Patients in the treatment group will receive intra-venous hydrocortisone. Patients of the control group will receive an intravenous placebo by intravenous route at the same frequency.
Hydrocortisone or placebo will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement.
A substantial amendment to the CAPE COD study has been submitted to the Competent Authorities in order to conduct a specific analysis on the sub-group of patients included with COVID19 (coronavirus disease 2019), in order to get a quick response in this specific population and in the context of an epidemic emergency.
The aim is to answer as quickly as possible a therapeutic question of major importance in the treatment of severe respiratory infections with CoV-2 SARS (severe acute respiratory syndrome coronavirus 2). Modifications made to the original study for patients with COVID (coronavirus disease) include some inclusion criteria, the primary endpoint, and secondary endpoints.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Hydrocortisone, Placebo
- Keywords
- Community-Acquired Pneumonia (CAP), Hydrocortisone, Corticosteroids, COronaVIrus Disease
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Hydrocortisone will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement.
PlaceboDrug
Placebo will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | Patients in the treatment group will receive intra-venous hydrocortisone (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP) Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | Patients of the control group will receive an intravenous placebo by intravenous route (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28 all causes mortality
Measured: at day 28
Day 21 failure
For the sub-group of patients included with COVID19, failure is defined as death or need of respiratory support (mechanical ventilation or high-flow oxygen therapy);
Measured: at day 21
Secondary outcomes (18)
In patients non-invasively ventilated at inclusion, proportion of patients needing endotracheal intubation
Measured: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
In patients non-ventilated at inclusion, proportion of patients requiring non-invasive ventilation
Measured: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
In patients non-ventilated at inclusion, proportion of patients needing endotracheal intubation
Measured: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
Day 28 ventilator-free-days
Measured: between 0 and day 28
Number of patients with vasopressor therapy initiation from inclusion to day 28
Measured: between 0 and day 28
Day 28 vasopressor-free-days
Measured: between 0 and day 28
ICU and/or intermediate care unit LOS
Measured: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
All-causes mortality at day 90
Measured: at day 90
SF-36 Health Survey at day 90
Measured: at day 90
Biomarkers: procalcitonin at baseline, day 3 and day 7
Measured: at inclusion, day 3 and day 7
Biomarkers: C-reactive protein at baseline, day 3 and day 7
Measured: at inclusion, day 3 and day 7
Biomarkers: plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF) at baseline, day 3 and day 7
Measured: at inclusion, day 3 and day 7
P/F ratio measured daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28
Measured: measured daily from baseline to day 7, at the end of treatment i.e 14 days after the start of treatment, at the end of ICU-stay (for a maximum of 28 days) and/or day 28
SOFA calculated daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28
Measured: calculated daily from baseline to day 7, at the end of treatment (i.e 14 days after the start of treatment), at the end of ICU-stay (for a maximum of 28 days) and/or day 28
Proportion of patients experiencing secondary infection during their ICU-stay
Measured: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
Proportion of patients experiencing gastrointestinal bleeding during their ICU-stay
Measured: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
Daily amount of insulin administered to the patient from day 1 to day 7
Measured: Patients will be followed from day 1 to day 7
Weight-gain at baseline and day 7
Measured: Patients will be followed at baseline and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start28 Oct 2015
- Primary completion19 Jul 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-François DEQUIN, MD-PhD, Principal investigator, CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517489
- Sponsor's protocol ID
- PHRN14-PFD/CAPE COD
- Acronym
- CAPE_COD
- Status last verified
- Jan 2023
- First submitted
- 31 Jul 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dequin PF, Heming N, Meziani F, Plantefeve G, Voiriot G, Badie J, Francois B, Aubron C, Ricard JD, Ehrmann S, Jouan Y, Guillon A, Leclerc M, Coffre C, Bourgoin H, Lengelle C, Caille-Fenerol C, Tavernier E, Zohar S, Giraudeau B, Annane D, Le Gouge A; CAPE COVID Trial Group and the CRICS-TriGGERSep Network. Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1298-1306. doi: 10.1001/jama.2020.16761.
PubMed 32876689Friedrich JO, Gouvea Bogossian E. Hydrocortisone in Severe Community-Acquired Pneumonia. N Engl J Med. 2023 Aug 17;389(7):670-671. doi: 10.1056/NEJMc2307400. No abstract available.
PubMed 37585638Dequin PF, Meziani F, Quenot JP, Kamel T, Ricard JD, Badie J, Reignier J, Heming N, Plantefeve G, Souweine B, Voiriot G, Colin G, Frat JP, Mira JP, Barbarot N, Francois B, Louis G, Gibot S, Guitton C, Giacardi C, Hraiech S, Vimeux S, L'Her E, Faure H, Herbrecht JE, Bouisse C, Joret A, Terzi N, Gacouin A, Quentin C, Jourdain M, Leclerc M, Coffre C, Bourgoin H, Lengelle C, Caille-Fenerol C, Giraudeau B, Le Gouge A; CRICS-TriGGERSep Network. Hydrocortisone in Severe Community-Acquired Pneumonia. N Engl J Med. 2023 May 25;388(21):1931-1941. doi: 10.1056/NEJMoa2215145. Epub 2023 Mar 21.
PubMed 36942789
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02517489
- Acronym / sponsor ID
- CAPE_COD / PHRN14-PFD/CAPE COD
- Conditions
- Community Acquired Pneumonia
- Keywords
- Community-Acquired Pneumonia (CAP), Hydrocortisone, Corticosteroids, COronaVIrus Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 19 Jul 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 7 Aug 2015 (estimated)
- 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.
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.
A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia.
Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.
Detailed description
Patients will receive state-of-the-art standard therapy for severe Community-Acquired Pneumonia (CAP), including antibiotics and supportive care. Correction of hypoxemia will use standard low-flow oxygen therapy, high-flow oxygen therapy, non-invasive-ventilation or invasive ventilation with endotracheal tube, as required. Patients in the treatment group will receive intra-venous hydrocortisone. Patients of the control group will receive an intravenous placebo by intravenous route at the same frequency.
Hydrocortisone or placebo will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement.
A substantial amendment to the CAPE COD study has been submitted to the Competent Authorities in order to conduct a specific analysis on the sub-group of patients included with COVID19 (coronavirus disease 2019), in order to get a quick response in this specific population and in the context of an epidemic emergency.
The aim is to answer as quickly as possible a therapeutic question of major importance in the treatment of severe respiratory infections with CoV-2 SARS (severe acute respiratory syndrome coronavirus 2). Modifications made to the original study for patients with COVID (coronavirus disease) include some inclusion criteria, the primary endpoint, and secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Drug: HydrocortisonePatients in the treatment group will receive intra-venous hydrocortisone (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP) |
| Placebo | Placebo comparator | Drug: PlaceboPatients of the control group will receive an intravenous placebo by intravenous route (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years
- Patients affiliated to social security scheme
- Admission to an Intensive Care Unit (ICU) or intermediate care unit participating to the trial
- Diagnosis of Community- Acquired Pneumonia (CAP) suggested by at least two of the following: cough, purulent sputum, chest pain and dyspnea
- Focal shadowing/infiltrate on chest X-ray or CT-scan
Key exclusion criteria (17 listed)
- Patient treated by vasopressors for septic shock at the time of inclusion
- Clinical history suggesting of aspiration of gastric content
- Patient treated by invasive mechanical ventilation within 14 days before current hospital admission
- Patient treated by antibiotics for a respiratory infection for more than seven days at the admission to the hospital (except if a pathogen resistant to this antibiotics is isolated)
- History of cystic fibrosis
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 |
|---|---|---|
| HydrocortisoneHydrocortisone will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement. | Drug | Hydrocortisone |
| PlaceboPlacebo will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement. | Drug | Placebo |
Primary outcome
Day 28 all causes mortality
Time frame: at day 28
Day 21 failure
Time frame: at day 21
For the sub-group of patients included with COVID19, failure is defined as death or need of respiratory support (mechanical ventilation or high-flow oxygen therapy);
18 secondary outcomes
In patients non-invasively ventilated at inclusion, proportion of patients needing endotracheal intubation
Time frame: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
In patients non-ventilated at inclusion, proportion of patients requiring non-invasive ventilation
Time frame: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
In patients non-ventilated at inclusion, proportion of patients needing endotracheal intubation
Time frame: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
Day 28 ventilator-free-days
Time frame: between 0 and day 28
Number of patients with vasopressor therapy initiation from inclusion to day 28
Time frame: between 0 and day 28
Day 28 vasopressor-free-days
Time frame: between 0 and day 28
ICU and/or intermediate care unit LOS
Time frame: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
All-causes mortality at day 90
Time frame: at day 90
SF-36 Health Survey at day 90
Time frame: at day 90
Biomarkers: procalcitonin at baseline, day 3 and day 7
Time frame: at inclusion, day 3 and day 7
Biomarkers: C-reactive protein at baseline, day 3 and day 7
Time frame: at inclusion, day 3 and day 7
Biomarkers: plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF) at baseline, day 3 and day 7
Time frame: at inclusion, day 3 and day 7
P/F ratio measured daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28
Time frame: measured daily from baseline to day 7, at the end of treatment i.e 14 days after the start of treatment, at the end of ICU-stay (for a maximum of 28 days) and/or day 28
SOFA calculated daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28
Time frame: calculated daily from baseline to day 7, at the end of treatment (i.e 14 days after the start of treatment), at the end of ICU-stay (for a maximum of 28 days) and/or day 28
Proportion of patients experiencing secondary infection during their ICU-stay
Time frame: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
Proportion of patients experiencing gastrointestinal bleeding during their ICU-stay
Time frame: Participants will be followed for the duration of hospital stay, for a maximum of 28 days
Daily amount of insulin administered to the patient from day 1 to day 7
Time frame: Patients will be followed from day 1 to day 7
Weight-gain at baseline and day 7
Time frame: Patients will be followed at baseline and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 32876689Dequin PF, Heming N, Meziani F, Plantefeve G, Voiriot G, Badie J, Francois B, Aubron C, Ricard JD, Ehrmann S, Jouan Y, Guillon A, Leclerc M, Coffre C, Bourgoin H, Lengelle C, Caille-Fenerol C, Tavernier E, Zohar S, Giraudeau B, Annane D, Le Gouge A; CAPE COVID Trial Group and the CRICS-TriGGERSep Network. Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1298-1306. doi: 10.1001/jama.2020.16761.
- Derived from this study: PubMed 37585638Friedrich JO, Gouvea Bogossian E. Hydrocortisone in Severe Community-Acquired Pneumonia. N Engl J Med. 2023 Aug 17;389(7):670-671. doi: 10.1056/NEJMc2307400. No abstract available.
- Derived from this study: PubMed 36942789Dequin PF, Meziani F, Quenot JP, Kamel T, Ricard JD, Badie J, Reignier J, Heming N, Plantefeve G, Souweine B, Voiriot G, Colin G, Frat JP, Mira JP, Barbarot N, Francois B, Louis G, Gibot S, Guitton C, Giacardi C, Hraiech S, Vimeux S, L'Her E, Faure H, Herbrecht JE, Bouisse C, Joret A, Terzi N, Gacouin A, Quentin C, Jourdain M, Leclerc M, Coffre C, Bourgoin H, Lengelle C, Caille-Fenerol C, Giraudeau B, Le Gouge A; CRICS-TriGGERSep Network. Hydrocortisone in Severe Community-Acquired Pneumonia. N Engl J Med. 2023 May 25;388(21):1931-1941. doi: 10.1056/NEJMoa2215145. Epub 2023 Mar 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pierre-François DEQUIN, MD-PhD principal investigator
CHRU de TOURS
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone in people with Community Acquired Pneumonia, run by University Hospital, Tours at 32 sites in France.
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 19 inclusion and 17 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 28 all causes mortality (time frame: at day 28). 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?
On the ClinicalTrials.gov record for NCT02517489, which also lists 3 linked publications.
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 22 Dec 2025.