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NCT Number: NCT06755814

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Via Francesco Sforza 35 20122 Milan Italy

Milan, Milano, 20122, Italy

Location status: Recruiting

Location contact

Concetta Sirena

CONTACT

[email protected]

Francesco B.A. Blasi, Professor, MD, FERS

CONTACT

[email protected]

0250320627 ext. +39

Francesco B.A. Blasi, Professor, MD, FERS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Length of hospital stay (days)

    Time frame: Through hospital discharge, ranging from 1 day to 2 weeks

  6. ICU admission %

    Time frame: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)

  7. Need for mechanical ventilation %

    Time frame: During hospitalization (1 day to 2 weeks on average)

  8. Lenght of mechanical ventilation (Hours)

    Time frame: During hospitalization (1 day to 2 weeks on average)

  9. Rate of antibiotic therapy modification (%)

    Time frame: During hospitalization (1 day to 2 weeks on average)

  10. Subsequent re-admission within 1 year

    Time frame: Within 365 days after hospital discharge

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Concetta Sirena, Phd

CONTACT

[email protected]

342 0790871 ext. +39

Francesco B.A. Blasi, MD,

CONTACT

[email protected]

0250320627 ext. +39

Sponsors and collaborators

Lead sponsor

Societa Italiana di Pneumologia

Other

Registry information

Official study title

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

Acronym: ARGONAUT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 1, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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