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Community Acquired Pneumonia (CAP)ARGONAUTNCT06755814

ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)

An observational study of Community Acquired Pneumonia (CAP), run by Societa Italiana di Pneumologia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community Acquired Pneumonia (CAP)
How many people
1,298 participants
Where
1 siteItaly
Study dates
11 Aug 2025to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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;
Show all 18Show fewer
  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Francesco B.A. Blasi, MD, contact

0250320627 ext. +39

francesco.blasi@unimi.it

Concetta Sirena, Phd contact

342 0790871 ext. +39

ricerche@sipirs.it

Italy1 site, 1 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

    Milan, Milano, 20122

    Francesco B.A. Blasi, Professor, MD, FERS, 0250320627 ext. +39, francesco.blasi@unimi.it

    Concetta Sirena, ricerche@sipirs.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Keywords
CAP, Immunosuppressed, Immunocompromised, Pneumonia, community-acquired pneumonia;
Medical subject headings
Community-Acquired Pneumonia, Pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.

    Recording in-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.

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

Secondary outcomes (11)

  1. Time to clinical stability

    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.

    Measured: DAY 1 to 8

  2. Mortality for all causes in immunocompromised patients with CAP

    Mortality for all causes in immunocompromised patients with CAP enrolled in the study.

    Measured: 30 days, 3 months, 6 months and 12 months after hospital discharge.

  3. New hospitalizations in immunocompromised patients with CAP.

    Recording new hospitalizations in immunocompromised patients with CAP enrolled in the study.

    Measured: 30 days, 3 months, 6 months and 12 months after hospital discharge.

  4. Prevalence of cardiovascular events in immunocompromised patients with CAP.

    Prevalence of cardiovascular events in immunocompromised patients with CAP enrolled in the study.

    Measured: 30 days, 3 months, 6 months and 12 months after hospital discharge.

  5. Length of hospital stay (days)

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

  6. ICU admission %

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

  7. Need for mechanical ventilation %

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

  8. Lenght of mechanical ventilation (Hours)

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

  9. Rate of antibiotic therapy modification (%)

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

  10. Subsequent re-admission within 1 year

    Measured: Within 365 days after hospital discharge

  11. Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing

    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.

    Measured: Through study completion, for up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start11 Aug 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06755814
Sponsor's protocol ID
4656/ 2024
Acronym
ARGONAUT
Status last verified
Dec 2024
First submitted
19 Nov 2024
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garcia-Vidal C, Fernandez-Sabe N, Carratala J, Diaz V, Verdaguer R, Dorca J, Manresa F, Gudiol F. Early mortality in patients with community-acquired pneumonia: causes and risk factors. Eur Respir J. 2008 Sep;32(3):733-9. doi: 10.1183/09031936.00128107. Epub 2008 May 28.

    PubMed 18508820

  • Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.

    PubMed 31573350

  • Aliberti S, Cilloniz C, Chalmers JD, Zanaboni AM, Cosentini R, Tarsia P, Pesci A, Blasi F, Torres A. Multidrug-resistant pathogens in hospitalised patients coming from the community with pneumonia: a European perspective. Thorax. 2013 Nov;68(11):997-9. doi: 10.1136/thoraxjnl-2013-203384. Epub 2013 Jun 17.

    PubMed 23774884

  • Evans SE, Ost DE. Pneumonia in the neutropenic cancer patient. Curr Opin Pulm Med. 2015 May;21(3):260-71. doi: 10.1097/MCP.0000000000000156.

    PubMed 25784246

  • Feldman C. Pneumonia associated with HIV infection. Curr Opin Infect Dis. 2005 Apr;18(2):165-70. doi: 10.1097/01.qco.0000160907.79437.5a.

    PubMed 15735422

  • Di Pasquale MF, Sotgiu G, Gramegna A, Radovanovic D, Terraneo S, Reyes LF, Rupp J, Gonzalez Del Castillo J, Blasi F, Aliberti S, Restrepo MI; GLIMP Investigators. Prevalence and Etiology of Community-acquired Pneumonia in Immunocompromised Patients. Clin Infect Dis. 2019 Apr 24;68(9):1482-1493. doi: 10.1093/cid/ciy723.

    PubMed 31222287

  • Carugati M, Aliberti S, Sotgiu G, Blasi F, Gori A, Menendez R, Encheva M, Gallego M, Leuschner P, Ruiz-Buitrago S, Battaglia S, Fantini R, Pascual-Guardia S, Marin-Corral J, Restrepo MI; GLIMP Collaborators. Bacterial etiology of community-acquired pneumonia in immunocompetent hospitalized patients and appropriateness of empirical treatment recommendations: an international point-prevalence study. Eur J Clin Microbiol Infect Dis. 2020 Aug;39(8):1513-1525. doi: 10.1007/s10096-020-03870-3. Epub 2020 Apr 3.

    PubMed 32242314

  • Ramirez JA, Musher DM, Evans SE, Dela Cruz C, Crothers KA, Hage CA, Aliberti S, Anzueto A, Arancibia F, Arnold F, Azoulay E, Blasi F, Bordon J, Burdette S, Cao B, Cavallazzi R, Chalmers J, Charles P, Chastre J, Claessens YE, Dean N, Duval X, Fartoukh M, Feldman C, File T, Froes F, Furmanek S, Gnoni M, Lopardo G, Luna C, Maruyama T, Menendez R, Metersky M, Mildvan D, Mortensen E, Niederman MS, Pletz M, Rello J, Restrepo MI, Shindo Y, Torres A, Waterer G, Webb B, Welte T, Witzenrath M, Wunderink R. Treatment of Community-Acquired Pneumonia in Immunocompromised Adults: A Consensus Statement Regarding Initial Strategies. Chest. 2020 Nov;158(5):1896-1911. doi: 10.1016/j.chest.2020.05.598. Epub 2020 Jun 16.

    PubMed 32561442

Questions about this trial

What is this clinical trial studying?

An observational study of Community Acquired Pneumonia (CAP), run by Societa Italiana di Pneumologia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesco B.A. Blasi, MD, (0250320627 ext. +39, francesco.blasi@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06755814, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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