ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT) (ARGONAUT)

November 14, 2025 updated by: Societa Italiana di Pneumologia

Community-acquired Pneumonia in Immunosuppressed Adult Patients: Observational, Perspective Study, ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1298

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Via Francesco Sforza 35 20122 Milan Italy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco B.A. Blasi, Professor, MD, FERS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Recording in-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical stability
Time Frame: DAY 1 to 8
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.
DAY 1 to 8
Mortality for all causes in immunocompromised patients with CAP
Time Frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
Mortality for all causes in immunocompromised patients with CAP enrolled in the study.
30 days, 3 months, 6 months and 12 months after hospital discharge.
New hospitalizations in immunocompromised patients with CAP.
Time Frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
Recording new hospitalizations in immunocompromised patients with CAP enrolled in the study.
30 days, 3 months, 6 months and 12 months after hospital discharge.
Prevalence of cardiovascular events in immunocompromised patients with CAP.
Time Frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.
Prevalence of cardiovascular events in immunocompromised patients with CAP enrolled in the study.
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
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)
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)
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)
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)
During hospitalization (1 day to 2 weeks on average)
Subsequent re-admission within 1 year
Time Frame: Within 365 days after hospital discharge
Within 365 days after hospital discharge
Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing
Time Frame: Through study completion, for up to 4 years
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.
Through study completion, for up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societa Italiana di Pneumologia

Investigators

  • Study Chair: Francesco B.A. Blasi, MD, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4656/ 2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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