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Fulminant Severe CAP - an Observational Study

Fulminant Cases Among Severe Community-acquired Pneumonia - an Observational Retrospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06516601
Acronym
FULMISCAP
Enrollment
1460
Registered
2024-07-24
Start date
2018-01-02
Completion date
2024-10-01
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human, Community-acquired Pneumonia, Sepsis, Severe Pneumonia

Keywords

fulminant pneumonia, community acquired pneumonia, ARDS, sepsis, corticosteroids

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 ARDS/acute 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 CAP/ARDS 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 and/or severe pneumonia diagnosis. The use of corticosteroids varied from several reasons (e.g. RCT protocol, internal policy, physician on duty with not restriction to this. Both COVID and non-COVID patients were recruited if PaO2:FiO2 \<300, bilateral community acquired pneumonia, and 2 or more of the following: increased CRP \> 99mg/L, respiratory rate\>25bpm or signs of respiratory distress, need for respiratory support (CPAP, MV, HFNC), creatinine\>1,49mg/dl, ALT\>70. Hospital-acquired and Healthcare-acquired pneumonia were excluded. Also, chronic end-stage illness (e..g. 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).

Interventions

OTHERno intervention

observational study, the patients received corticosteroids according to the physician on duty

Sponsors

University of Trieste
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

severe community acquired pneumonia according to ATS/IDSA -

Exclusion criteria

incomplete outcome data \-

Design outcomes

Primary

MeasureTime frameDescription
mortality2days, 7days, 30days, 60daysmortality in hospital

Countries

Italy

Contacts

Primary ContactMARCO CONFALONIERI, MD
mconfalonieri@units.it+390403994667
Backup ContactFrancesco Salton, MD
francesco.salton@gmail.com+390403994667

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026