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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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,
• Email: francesco.blasi@unimi.it
• Phone: 0250320627

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.