An observational study in Community Acquired Pneumonia (CAP), sponsored by Societa Italiana di Pneumologia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Societa Italiana di Pneumologia · Observational
This multicentric, prospective study aims at:
evaluating the prevalence, etiology, characteristics, and 1one-year outcomes of immunocompromised patients hospitalized for Community-Acquired Pneumonia (CAP); conducting biochemical, microbiological and genetic analysis on collected samples.
Primary endpoint:
Collection of in- hospitalisation mortality for all causes in immunocompromised patients with CAP enrolled.
Secondary endpoints:
Collection of data on admission and during hospitalisation to evaluate clinical response to empirical treatments (including antibiotic therapy) related to severity of disease and microbiological etiology.
Prevalence of cardiovascular events and all-cause mortality during hospitalization or after discharge.
Biochemical, microbiological and genetic analysis on collected samples.
82 studies on the registry are indexed under Community-Acquired Pneumonia; 51 are open to participants now.
This study's planned enrollment of 1,298 is above the median of 650 across 27 observational studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →Societa Italiana di Pneumologia is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Immunosuppressed patients with Community-Acquired Pneumonia will be enrolled during hospitalization in Italian Pneumology, Infectious Diseases and Emergency Departments selected on their specific experteeze and know-how. Upon discharge, patients will be followed up at 30 days, 3 months, 6 months and 12 months after discharge.
Hospitalized patients with a confirmed diagnosis of Community-Acquired Pneumonia (CAP) characterized by at least one of the following risk factors for immunosuppression:
Exclusion Criteria:
In-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
Recording in-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
Time frame: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)
Time to clinical stability
Time to clinical stability calculated as the number of days from the date of admission to the date that the patient meets clinical stability criteria, up to 8 days. Clinical stability is defined as follows: improved clinical signs (improved cough and shortness of breath), lack of fever for at least 8 hours, improving leukocytosis (decreased at least 10% from the previous day), and tolerating oral intake.
Time frame: DAY 1 to 8
Mortality for all causes in immunocompromised patients with CAP
Mortality for all causes in immunocompromised patients with CAP enrolled in the study.
Time frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
New hospitalizations in immunocompromised patients with CAP.
Recording new hospitalizations in immunocompromised patients with CAP enrolled in the study.
Time frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
Prevalence of cardiovascular events in immunocompromised patients with CAP.
Prevalence of cardiovascular events in immunocompromised patients with CAP enrolled in the study.
Time frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
Length of hospital stay (days)
Time frame: Through hospital discharge, ranging from 1 day to 2 weeks
ICU admission %
Time frame: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)
Need for mechanical ventilation %
Time frame: During hospitalization (1 day to 2 weeks on average)
Lenght of mechanical ventilation (Hours)
Time frame: During hospitalization (1 day to 2 weeks on average)
Rate of antibiotic therapy modification (%)
Time frame: During hospitalization (1 day to 2 weeks on average)
Subsequent re-admission within 1 year
Time frame: Within 365 days after hospital discharge
Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing
Microbiological analysis will be performed on sputum, bronchoalveolar lavage (BAL), and bronchial aspirate (BAS) samples. The 16S rRNA sequencing will be conducted to evaluate the relative abundance of identified bacterial genera (percentage/total) and to calculate alpha diversity indices, including Shannon and Equitability indices. For samples where bacterial strains are isolated, whole-genome sequencing (WGS) will be performed to identify and study resistance, virulence, and pathogenicity genes. These findings will be correlated with clinical data to provide insights into microbiological etiology. Data will be summarized as relative abundances, diversity indices, and the presence/absence of key genomic features.
Time frame: Through study completion, for up to 4 years
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Societa Italiana di Pneumologia