CompletedPhase 3

Community-Acquired Pneumonia : Evaluation of Corticosteroids

France952 participantsStarted 2015-10-28

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

What they're measuring

Day 28 all causes mortality

Timeframe: at day 28

Day 21 failure

Timeframe: at day 21

Trial details

NCT IDNCT02517489

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-19