ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)

Official title

Community-acquired Pneumonia in Immunosuppressed Adult Patients: Observational, Perspective Study, ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)

Overview

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.

Primary outcome measures

• 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)]

Secondary outcome measures (11)

• Time to clinical stability [Time frame: DAY 1 to 8]
• Mortality for all causes in immunocompromised patients with CAP [Time frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.]
• New hospitalizations in immunocompromised patients with CAP. [Time frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.]
• Prevalence of cardiovascular events in immunocompromised patients with CAP. [Time frame: 30 days, 3 months, 6 months and 12 months after hospital discharge.]
• Length of hospital stay (days) [Time frame: Through hospital discharge, ranging from 1 day to 2 weeks]
• ICU admission % [Time frame: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)]
• Need for mechanical ventilation % [Time frame: During hospitalization (1 day to 2 weeks on average)]
• Lenght of mechanical ventilation (Hours) [Time frame: During hospitalization (1 day to 2 weeks on average)]
• Rate of antibiotic therapy modification (%) [Time frame: During hospitalization (1 day to 2 weeks on average)]
• Subsequent re-admission within 1 year [Time frame: Within 365 days after hospital discharge]
• Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing [Time frame: Through study completion, for up to 4 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCC — Milan

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. PMID 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):e PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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, Plet PMID 32561442

Identifiers

NCT: NCT06755814 · 4656/ 2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗