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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco B.A. Blasi, MD, | Contact | 0250320627 | +39 | francesco.blasi@unimi.it |
| Concetta Sirena, Phd | Contact | 342 0790871 | +39 | ricerche@sipirs.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco B.A. Blasi, MD | Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico Milano Via Francesco Sforza 35 20122 Milan Italy | Recruiting | Milan | Milano | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18508820 | Background | 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. | |
| 31573350 | 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. |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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Whole blood Serum Sputum BAL (bronchoalveolar lavage) or BAS (bronchoalveolar aspirate)
| DAY 1 to 8 |
| Mortality for all causes in immunocompromised patients with CAP | Mortality for all causes in immunocompromised patients with CAP enrolled in the study. | 30 days, 3 months, 6 months and 12 months after hospital discharge. |
| New hospitalizations in immunocompromised patients with CAP. | Recording new hospitalizations in immunocompromised patients with CAP enrolled in the study. | 30 days, 3 months, 6 months and 12 months after hospital discharge. |
| Prevalence of cardiovascular events in immunocompromised patients with CAP. | Prevalence of cardiovascular events in immunocompromised patients with CAP enrolled in the study. | 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 |
| ICU admission % | During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average) |
| Need for mechanical ventilation % | During hospitalization (1 day to 2 weeks 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) |
| Subsequent re-admission within 1 year | Within 365 days after hospital discharge |
| 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. | Through study completion, for up to 4 years |
|
| 23774884 | 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. |
| 25784246 | 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. |
| 15735422 | 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. |
| 31222287 | 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. |
| 32242314 | 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. |
| 32561442 | 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. |
| D008171 | Lung Diseases |