Fulminant Severe CAP - an Observational Study (FULMISCAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; ARDS, Human; Community-acquired Pneumonia; Severe Pneumonia
• Intervention / Treatment: Other: no intervention

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).

• Study Type: Observational
• Enrollment (Estimated): 1460

Contacts and Locations

• Study Contact: Name: MARCO CONFALONIERI, MD; Phone Number: +390403994667; Email: mconfalonieri@units.it
• Study Contact Backup: Name: Francesco Salton, MD; Phone Number: +390403994667; Email: francesco.salton@gmail.com

Study Locations

• Italy
  • Trieste, Italy, 34126
    • Recruiting
    • SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina
    • Contact: Francesco Salton, MD; Phone Number: 00390403994667; Email: francesco.salton@asugi.sanita.fvg.it
  • TS
    • Trieste, TS, Italy, 34149
      • Recruiting
      • Marco Confalonieri
      • Contact: marco confalonieri, MD; Phone Number: 4667 +39040399; Email: mconfalonieri@units.it
      • Contact: Francesco Salton, MD; Phone Number: +393486986287; Email: francesco.salton@gmail.com
      • Principal Investigator: Sergio Harari, Prof
      • Principal Investigator: Michele Mondoni, Prof.
      • Principal Investigator: Umberto Zuccon, Dr.
      • Principal Investigator: Jesus Vilar, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All the consecutive patients hospitalized for severe CAP in 4 hospitals

Description

Inclusion Criteria: severe community acquired pneumonia according to ATS/IDSA -

Exclusion Criteria: incomplete outcome data

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality in hospital	2days, 7days, 30days, 60days

Collaborators and Investigators

• Sponsor: University of Trieste
• Investigators: Principal Investigator: MARCO CONFALONIERI, MD, University of Trieste

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; sepsis; corticosteroids; community acquired pneumonia; fulminant pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Pneumonia; Respiratory Distress Syndrome
• Other Study ID Numbers: CEUR-2024-OS-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No