ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)

NCT06755814 | Recruiting

• 1 other identifier: 4656/ 2024
• Study Type: observational
• Target: 1,298
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Acquired Pneumonia (CAP)

Keywords

CAP; Immunosuppressed; Immunocompromised; Pneumonia; community-acquired pneumonia;

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• Time to clinical stability

  DAY 1 to 8

• Mortality for all causes in immunocompromised patients with CAP

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

• New hospitalizations 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.

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

• Length of hospital stay (days)

  Through hospital discharge, ranging from 1 day to 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• None

Sponsors & Collaborators

• Societa Italiana di Pneumologia: lead

Study Sites (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

Milan, Milano, 20122, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 18508820 BACKGROUND

• 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.

  PMID: 31573350 BACKGROUND

• 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.

  PMID: 23774884 BACKGROUND

• 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.

  PMID: 25784246 BACKGROUND

• 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.

  PMID: 15735422 BACKGROUND

• 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.

  PMID: 31222287 BACKGROUND

• 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.

  PMID: 32242314 BACKGROUND

• 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.

  PMID: 32561442 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum Sputum BAL (bronchoalveolar lavage) or BAS (bronchoalveolar aspirate)

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Francesco B.A. Blasi, MD

  Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

  STUDY CHAIR

Central Study Contacts

Francesco B.A. Blasi, MD,

CONTACT

0250320627; francesco.blasi@unimi.it

Concetta Sirena, Phd

CONTACT

342 0790871; ricerche@sipirs.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: January 1, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2024-12

Locations

IT (1)