Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02517489
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2015-07-31
Brief Title:
Community-Acquired Pneumonia Evaluation of Corticosteroids
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPE_COD
Brief 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
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 mgday by continuous infusion 2 or 4 days of half dose 100 mgday by continuous infusion and 2 or 3 days of tapering dose 50 mgday 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
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 mgday by continuous infusion 2 or 4 days of half dose 100 mgday by continuous infusion and 2 or 3 days of tapering dose 50 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None