A Phase 3 interventional study of Hydrocortisone and Placebo in Community Acquired Pneumonia, sponsored by University Hospital, Tours. Completed at 32 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by University Hospital, Tours · Phase 3, Interventional, and Treatment
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.
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.
82 studies on the registry are indexed under Community-Acquired Pneumonia; 51 are open to participants now.
This study's enrollment of 952 is above the median of 326 across 53 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severity defined by at least one of the following:
Oxygen flow (L/min) 6 7 8 9 10 or more PaO2 (mmHg) less than 180 210 240 270 300
On the sub-group of patients included with COVID19 :
Exclusion Criteria:
Patients in the treatment group will receive intra-venous hydrocortisone (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP)
Drug: Hydrocortisone
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)
Drug: Placebo
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.
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.
Day 28 all causes mortality
Time frame: 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);
Time frame: at day 21
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
P/F ratio measured daily from Day1 to Day7, at Day 14 and at Day 21 and/or at the end of ICU-stay
Sub-group of patients included with COVID19
Time frame: from day 1 to day 7, at day 14 and day 21 and/or at the end of ICU-stay
Proportion of patients needing endotracheal intubation
Sub-group of patients included with COVID19
Time frame: at day 21
Proportion of patients experiencing secondary infection during their ICU-stay
Sub-group of patients included with COVID19
Time frame: From baseline to day 21
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Tours