Community-Acquired Pneumonia : Evaluation of Corticosteroids
NCT ID: NCT02517489
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
952 participants
INTERVENTIONAL
2015-10-28
2020-08-28
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hydrocortisone
Patients in the treatment group will receive intra-venous hydrocortisone (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP)
Hydrocortisone
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
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)
Placebo
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.
Interventions
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Hydrocortisone
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Pierre-François DEQUIN, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU de TOURS
Locations
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Service de Réanimation - Unité de Soins Continus, CH d'Angoulême
Angoulême, , France
Service de Réanimation Polyvalente, CH d'Argenteuil
Argenteuil, , France
Service de Réanimation, CHR Metz-Thionville
Ars-Laquenexy, , France
Service de Réanimation
Aulnay-sous-Bois, , France
Service de Réanimation
Belfort, , France
Service de Réanimation
Bourg-en-Bresse, , France
Service de Réanimation HIA Clermont-Tonnerre
Brest, , France
Service de Réanimation Médicale, CHU de Brest
Brest, , France
Service de Réanimation, CHU Côte de Nacre
Caen, , France
Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres
Chartres, , France
Service de Réanimation Médicale Polyvalente, Hôpital G Montpied
Clermont-Ferrand, , France
Service de Réanimation, Hôpital Louis Mourier
Colombes, , France
Service de Réanimation Médicale, CHU de Dijon
Dijon, , France
Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP
Garches, , France
Service de Réanimation Médicale, CHU de Grenoble
Grenoble, , France
Service de Réanimation Polyvalente, CHD La Roche sur Yon
La Roche-sur-Yon, , France
Service de Réanimation, CH Le Mans
Le Mans, , France
Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille
Lille, , France
Service de Réanimation Polyvalente, CHU de Limoges
Limoges, , France
Service de Réanimation Médicale, Hôpital Nord
Marseille, , France
Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban
Montauban, , France
Service de Réanimation Médicale, CHU de Nancy
Nancy, , France
Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes
Nantes, , France
Service de Réanimation Médicale, CHR d'Orléans
Orléans, , France
Service de Réanimation Médicale, Hôpital Cochin, APHP
Paris, , France
Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP
Paris, , France
Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers
Poitiers, , France
Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes
Rennes, , France
Service de Réanimation
Saint-Brieuc, , France
Service de Réanimation Polyvalente, CH de Saint Malo
St-Malo, , France
Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg
Strasbourg, , France
Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg
Strasbourg, , France
Countries
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References
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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.
Friedrich 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.
Dequin 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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PHRN14-PFD/CAPE COD
Identifier Type: -
Identifier Source: org_study_id