ARGONAUT: Italian registry of pneumonia in people with weakened immune systems

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

This project will collect clinical and lab data to see how community-acquired pneumonia affects hospitalized adults with weakened immune systems.

Quick facts

• Study type: Observational
• Enrollment: 1298 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Societa Italiana di Pneumologia (Academic / other)
• Drugs / interventions: trastuzumab, Chemotherapy, prednisone
• Locations: 1 site (Milan, Milano)
• Trial ID: NCT06755814 on ClinicalTrials.gov

What this trial studies

ARGONAUT is a prospective, multicenter registry enrolling hospitalized patients in Italy who have community-acquired pneumonia and defined immunosuppression risk factors. The primary outcome is in-hospital all-cause mortality, and secondary outcomes include clinical response to empirical treatments, prevalence of cardiovascular events, and one-year mortality. The study collects biochemical, microbiological, and genetic samples to define etiology and characteristics of infection. Data aim to link disease severity, microbiological findings, and treatment patterns with short- and longer-term patient outcomes.

Who should consider this trial

Good fit: Hospitalized adults with confirmed community-acquired pneumonia who have one or more defined immunosuppression risk factors (for example HIV/AIDS, recent chemotherapy, organ transplant, prolonged high-dose steroids, or hematologic malignancy).

Not a fit: People with mild CAP treated as outpatients, those without immunosuppression, or patients seeking experimental therapies should not expect direct treatment benefit from participation.

Why it matters

Potential benefit: If successful, the registry could help doctors better target treatments and follow-up to reduce mortality and complications in immunocompromised patients with CAP.

How similar studies have performed: Previous CAP registries have improved understanding of causes and outcomes, but comprehensive microbiological and genetic profiling specifically in immunocompromised cohorts is less common.

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

Where this trial is running

Milan, Milano

• 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, Italy (Recruiting)

Study contacts

• Study coordinator: Francesco B.A. Blasi, MD,

Conditions Community Acquired Pneumonia; CAP; Immunosuppressed; Immunocompromised; Pneumonia; community-acquired pneumonia