Fulminant Severe CAP - an Observational Study

NCT06516601 | Recruiting

• 1 other identifier: CEUR-2024-OS-6
• Study Type: observational
• Target: 1,460
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

fulminant pneumonia; community acquired pneumonia; ARDS; sepsis; corticosteroids

Outcome Measures

Primary Outcomes (1)

• mortality

  mortality in hospital

  2days, 7days, 30days, 60days

Interventions

no intervention OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the consecutive patients hospitalized for severe CAP in 4 hospitals

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (2)

Marco Confalonieri

Trieste, TS, 34149, Italy

RECRUITING

SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina

Trieste, 34126, Italy

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia; Respiratory Distress Syndrome; Sepsis

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MARCO CONFALONIERI, MD

  University of Trieste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARCO CONFALONIERI, MD

CONTACT

+390403994667; mconfalonieri@units.it

Francesco Salton, MD

CONTACT

+390403994667; francesco.salton@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: January 2, 2018
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

IT (2)