ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)
NCT ID: NCT06755814
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1298 participants
OBSERVATIONAL
2025-08-11
2028-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Societa Italiana di Pneumologia
OTHER
Responsible Party
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Principal Investigators
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Francesco B.A. Blasi, MD
Role: STUDY_CHAIR
Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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4656/ 2024
Identifier Type: -
Identifier Source: org_study_id
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