Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516601
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Fulminant Severe CAP - an Observational Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fulminant Cases Among Severe Community-acquired Pneumonia - an Observational Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FULMISCAP
Brief Summary:
Severe community-acquired pneumonia CAP represents a major cause of hospital mortality Among severe CAP cases some exhibit a rapidly progressive evolution leading to severe ARDSacute respiratory failure and septic shock within hours to a few days This type of pneumonia known as fulminant pneumonia is characterized by its rapid onset and deterioration often necessitating immediate medical intervention Despite its severity the true incidence and optimal treatment for fulminant pneumonia are not well understood This knowledge gap is due to the lack of attention towards pneumonia as a potential time-dependent illness and the separation of overlapping clinical topics severe pneumonia ARDS and sepsis
In clinical practice pneumonia is the most frequent cause of both ARDS and sepsis However these conditions are often considered separately combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia The COVID-19 pandemic with its vast number of severe CAP cases in a short period has highlighted the existence of fulminant pneumonias underscoring the need for further investigation Recent randomized clinical trials RCTs and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAPARDS of bacterial origin
The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia
In clinical practice pneumonia is the most frequent cause of both ARDS and sepsis However these conditions are often considered separately combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia The COVID-19 pandemic with its vast number of severe CAP cases in a short period has highlighted the existence of fulminant pneumonias underscoring the need for further investigation Recent randomized clinical trials RCTs and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAPARDS of bacterial origin
The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia
Detailed Description:
A list of consecutive patients with severe CAP from the 5 participating centers from January 2018 to July 2024 Patients recruited for concomitant randomized clinical trials were allowed Each Center used an early antibiotic policy 6 hours in case of sepsis andor severe pneumonia diagnosis The use of corticosteroids varied from several reasons eg RCT protocol internal policy physician on duty with not restriction to this
Both COVID and non-COVID patients were recruited if PaO2FiO2 300 bilateral community acquired pneumonia and 2 or more of the following increased CRP 99mgL respiratory rate25bpm or signs of respiratory distress need for respiratory support CPAP MV HFNC creatinine149mgdl ALT70 Hospital-acquired and Healthcare-acquired pneumonia were excluded Also chronic end-stage illness eg metastatic cancers advanced neuromuscolar disorders etc were excluded
The following patient caractheristics and clinical data were collected at admission oxygenation state vital signs age type of unit at admission admission to ICU length of hospital stay type and duration of mechanical ventilation MV initial and maximal PEEP administered ALT WBC platelets Haemoglobin presence of obesity comorbidities risk factors smoking abuse
Both COVID and non-COVID patients were recruited if PaO2FiO2 300 bilateral community acquired pneumonia and 2 or more of the following increased CRP 99mgL respiratory rate25bpm or signs of respiratory distress need for respiratory support CPAP MV HFNC creatinine149mgdl ALT70 Hospital-acquired and Healthcare-acquired pneumonia were excluded Also chronic end-stage illness eg metastatic cancers advanced neuromuscolar disorders etc were excluded
The following patient caractheristics and clinical data were collected at admission oxygenation state vital signs age type of unit at admission admission to ICU length of hospital stay type and duration of mechanical ventilation MV initial and maximal PEEP administered ALT WBC platelets Haemoglobin presence of obesity comorbidities risk factors smoking abuse
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None