Clinical trial NCT06755814: ItAlian ReGistry of PNeumoniA in ImmUnocompromised PaTients (ARGONAUT)
Official title: Community-acquired Pneumonia in Immunosuppressed Adult Patients: Observational, Perspective Study, ItAlian ReGistry of PNeumoniA in ImmUnocompromised PaTients (ARGONAUT)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Community Acquired Pneumonia (CAP)
Keywords: CAP
Immunosuppressed
Immunocompromised
Pneumonia
community-acquired pneumonia;
Lead sponsor: Societa Italiana di Pneumologia
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 1298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Hospitalized patients with a confirmed diagnosis of Community-Acquired Pneumonia (CAP) characterized by at least one of the following risk factors for immunosuppression:

* AIDS,
* Aplastic anemia;
* Asplenia;
* Hematologic malignancy (e.g., lymphoma/acute or chronic myeloid leukemia/multiple myeloma);
* Chemotherapy within the last 3 months;
* Neutropenia defined as a white blood cell count less than 500/dL on a complete blood count;
* Use of biologics (including trastuzumab and therapy for autoimmune diseases (e.g., anti-TNF α), prescribed within the last 6 months before hospital admission;
* Solid organ transplant;
* Bone marrow transplant;
* Chronic oral steroid use (\>10 mg/day prednisone or equivalent ≥3 months before accessing the ED, or cumulative dose \> 600 mg prednisone);
* Use of corticosteroid therapy with a dose ≥ 20 mg prednisone or equivalent ≥14 days or cumulative dose \> 600 mg prednisone;
* Active malignancy;
* Malignancy within one year of pneumonia (excluding patients with localized skin cancer or early-stage malignancy);
* Lung malignancy with neutropenia/chemotherapy;
* Other solid malignancy with neutropenia/chemotherapy;
* Other immunodeficiency (including congenital/genetic immunosuppression and immunosuppressive therapy secondary to hematologic malignancy or solid malignancy);
* Primary immunodeficiency.

Exclusion Criteria:

* None

Primary outcomes:
measure: In-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
timeFrame: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)
Secondary outcomes:
measure: Time to clinical stability
timeFrame: DAY 1 to 8
measure: Mortality for all causes in immunocompromised patients with CAP
timeFrame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
measure: New hospitalizations in immunocompromised patients with CAP.
timeFrame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
measure: Prevalence of cardiovascular events in immunocompromised patients with CAP.
timeFrame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
measure: Length of hospital stay (days)
timeFrame: Through hospital discharge, ranging from 1 day to 2 weeks
measure: ICU admission %
timeFrame: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)
measure: Need for mechanical ventilation %
timeFrame: During hospitalization (1 day to 2 weeks on average)
measure: Lenght of mechanical ventilation (Hours)
timeFrame: During hospitalization (1 day to 2 weeks on average)
measure: Rate of antibiotic therapy modification (%)
timeFrame: During hospitalization (1 day to 2 weeks on average)
measure: Subsequent re-admission within 1 year
timeFrame: Within 365 days after hospital discharge
measure: Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing
timeFrame: Through study completion, for up to 4 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Via Francesco Sforza 35 20122 Milan Italy
Study officials:
affiliation: Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
name: Francesco B.A. Blasi, MD
role: STUDY_CHAIR
References:
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