ItAlian ReGistry of PNeumoniA in ImmUnocompromised PaTients (ARGONAUT)
- Conditions
- Community Acquired Pneumonia (CAP)
- Registration Number
- NCT06755814
- Lead Sponsor
- Societa Italiana di Pneumologia
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1298
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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) Recording in-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
- Secondary Outcome Measures
Name Time Method Subsequent re-admission within 1 year Within 365 days after hospital discharge Time to clinical stability 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.
Mortality for all causes in immunocompromised patients with CAP 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.
New hospitalizations in immunocompromised patients with CAP. 30 days, 3 months, 6 months and 12 months after hospital discharge. Recording new hospitalizations in immunocompromised patients with CAP enrolled in the study.
Prevalence of cardiovascular events in immunocompromised patients with CAP. 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.
Length of hospital stay (days) Through hospital discharge, ranging from 1 day to 2 weeks Need for mechanical ventilation % During hospitalization (1 day to 2 weeks on average) ICU admission % During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average) Lenght of mechanical ventilation (Hours) During hospitalization (1 day to 2 weeks on average) Rate of antibiotic therapy modification (%) During hospitalization (1 day to 2 weeks on average) Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing 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.
Trial Locations
- Locations (1)
Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Via Francesco Sforza 35 20122 Milan Italy
🇮🇹Milano, Italy