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Could a cheap steroid save lives in severe pneumonia?

NCT ID NCT02517489

Disease control Sponsor: University Hospital, Tours 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether low-dose hydrocortisone, a common steroid, can help people with severe community-acquired pneumonia survive. Over 950 critically ill adults in intensive care received either the steroid or a placebo, alongside standard antibiotics and support. The goal was to see if the drug reduces deaths within 28 days.

What this could mean

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

Active substance
hydrocortisone (a corticosteroid drug)
What this could lead to
If successful, this could confirm that adding low-dose corticosteroids to standard care improves survival for people with severe pneumonia.
What could go wrong
This is a single phase 3 trial; results may not apply to all patients. Corticosteroids can have side effects like increased infection risk or blood sugar issues.

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

952 people

The number who actually took part.

Started

Oct 2015

Finished

Aug 2020

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: * 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 * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia COVID-19 pneumonia

As listed by the trial registrant

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

Community-acquired pneumonia

Contacts and locations

Locations

  • Service de Réanimation

    Aulnay-sous-Bois, 93602, France

  • Service de Réanimation

    Belfort, 90015, France

  • Service de Réanimation

    Bourg-en-Bresse, France

  • Service de Réanimation

    Saint-Brieuc, 22000, France

  • Service de Réanimation - Unité de Soins Continus, CH d'Angoulême

    Angoulême, 16959, France

  • Service de Réanimation HIA Clermont-Tonnerre

    Brest, 29240, France

  • Service de Réanimation Médicale Polyvalente, Hôpital G Montpied

    Clermont-Ferrand, 63003, France

  • Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers

    Poitiers, 86021, France

  • Service de Réanimation Médicale, CHR d'Orléans

    Orléans, 45067, France

  • Service de Réanimation Médicale, CHU de Brest

    Brest, 29609, France

  • Service de Réanimation Médicale, CHU de Dijon

    Dijon, 21079, France

  • Service de Réanimation Médicale, CHU de Grenoble

    Grenoble, 38043, France

  • Service de Réanimation Médicale, CHU de Nancy

    Nancy, 54511, France

  • Service de Réanimation Médicale, Hôpital Cochin, APHP

    Paris, 75014, France

  • Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres

    Chartres, 28000, France

  • Service de Réanimation Médicale, Hôpital Nord

    Marseille, 13015, France

  • Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg

    Strasbourg, 67098, France

  • Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg

    Strasbourg, 67091, France

  • Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP

    Garches, 92380, France

  • Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban

    Montauban, 82013, France

  • Service de Réanimation Polyvalente, CH d'Argenteuil

    Argenteuil, 95107, France

  • Service de Réanimation Polyvalente, CH de Saint Malo

    St-Malo, 35403, France

  • Service de Réanimation Polyvalente, CHD La Roche sur Yon

    La Roche-sur-Yon, 85925, France

  • Service de Réanimation Polyvalente, CHU de Limoges

    Limoges, 87042, France

  • Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes

    Nantes, 44093, France

  • Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille

    Lille, 59037, France

  • Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP

    Paris, 75020, France

  • Service de Réanimation, CH Le Mans

    Le Mans, 72037, France

  • Service de Réanimation, CHR Metz-Thionville

    Ars-Laquenexy, 57530, France

  • Service de Réanimation, CHU Côte de Nacre

    Caen, 14033, France

  • Service de Réanimation, Hôpital Louis Mourier

    Colombes, 92700, France

  • Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes

    Rennes, 35033, France

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