Study of Progression of Community Acquired Pneumonia in the Hospital

Sepsis Clinical Trial

— PROGRESS  

Official title:

Study of Progression of Hospitalized Community Acquired Pneumonia - Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782013
• Other study ID #: PROGRESS-CAP
• Status: Completed
• Start date: August 25, 2009
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pneumonia is a common infectious disease of the lung, often requiring treatment in the hospital. Clinical scoring systems are available, identifying patients not requiring hospitalization. However, the course of disease of patients in the hospital remains hard to predict. While most patients will recover quickly, some will, despite appropriate treatment, develop a severe course leading to sepsis and systemic responses resulting in organ dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular markers and combinations thereof predicting a severe course of pneumonia in the hospital. Such predictors will, for instance, support decisions on earlier transfer of patients to intensive care and thus improving outcome.

Description:

Pneumonia is a common infectious disease of the lung, often requiring treatment in the hospital. Clinical scoring systems are available, identifying patients not requiring hospitalization. However, the course of disease of patients in the hospital remains hard to predict. While most patients will recover quickly, some will, despite appropriate treatment, develop a severe course leading to sepsis and systemic responses resulting in organ dysfunction. The PROGRESS study aims to identify clinical, genetic and other molecular markers and combinations thereof predicting a severe course of pneumonia in the hospital. Such predictors will, for instance, support decisions on earlier transfer of patients to intensive care and thus improving outcome.

The PROGRESS study was initially approved by the ethics board of the University Hospital Jena, Friedrich-Schiller-University Jena, Germany (2403-10/08, November 6th, 2008) and subsequently by the ethics committees of all recruiting study centers.

In this observational, longitudinal case-cohort study, patients are enrolled within 48 hours of hospitalization and patient's progress is followed in much detail for up to six days thereafter. Further data are collected until discharge from the hospital. Patients are followed up on at days 28, 180, and 360 after enrollment.

Baseline assessment comprises sociodemographic, anamnestic, family history, and live style information. Upon enrollment, Pneumonia Severity Index (PSI) and CURB-65 are determined. For the day of enrollment and up to six subsequent study days routine laboratory and clinical observations and information on therapy are documented as well as data for determining the Sequential Organ Failure Assessment (SOFA) score, Systemic Inflammatory Response Syndrome (SIRS) status, and organ dysfunction. Starting with enrollment, up to six consecutive sets of biomaterials are collected comprising serum, plasma, and materials for extraction of RNA. Blood for extraction of DNA is collected once.

Follow up comprises vital status, housing situation, recurrence of pneumonia, and a quality of life questionnaire.

Analysis of cross sectional and time series data will identify clinical, genetic, and other molecular markers predicting a severe course of pneumonia in the hospital. Analysis of multilevel 'omics data in conjunction with clinical data will provide new insights into pathomechanistic details of pneumonia progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2309
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Hospitalization with community acquired pneumonia (CAP) confirmed by pulmonary infiltrate in chest radiograph

2. Working diagnosis of CAP by enrolling physician

3. Adult patient >= 18 years of age

4. Valid informed consent form

5. At least 2 out of the five following clinical symptoms:

• Fever

• Cough

• Purulent sputum

• Shortness of breath or need for respiratory support

• Crackling or rales on auscultation, dullness to percussion, or bronchial breathing

Exclusion Criteria:

1. Participation in this study at an earlier time

2. Hospitalization for any reason within 28 days prior to hospitalization for the current episode of CAP

3. More than 48 hours in the hospital before enrollment

4. Pregnancy

5. Breastfeeding

6. Decision on limitation of therapy before enrollment

7. Known HIV infection or AIDS

8. Anti-tumor treatment within the past six months

9. Post-stenotic pneumonia in conjunction with bronchial carcinoma

10. Therapy with corticosteroids = 20mg for = 14 days before enrollment

11. Non-steroidal immunosuppressive therapy within the past six months

12. Cytostatic therapy within the past six months

13. Radiation therapy within the past six months

14. Bone marrow transplant received

15. Respiratory support at home via tracheostoma

16. Cystic fibrosis

17. Active tuberculosis

18. Acute lung injury or acute respiratory distress syndrome for extrapulmonary reasons

19. Massive aspiration

20. Sepsis with extrapulmonary focus

21. Acute pulmonary embolism

22. Congestive heart failure New York Heart Association (NYHA) IV stadium

23. Liver insufficiency Child-Pugh C stadium

Related Conditions & MeSH terms

• Disease Progression
• Pneumonia
• Sepsis
• Shock, Septic

Locations

Country	Name	City	State
Austria	LKH-Univ. Klinikum Graz, UKIM Pulmologie	Graz
Austria	Allgemeines Krankenhaus der Stadt Linz, Abteilung Lungenheilkunde	Linz
Germany	Evangel. Krankenhausverein, Luisenhospital, Lungenzentrum	Aachen
Germany	Universitätsklinikum Aachen, Med. Klinik I (Pneumologie)	Aachen
Germany	Krankenhaus Angermünde, Klinik f. Innere Medizin / Pneumologie	Angermünde
Germany	Krankenhaus Bad Arolsen GmbH, Innere Medizin (Herz-, Kreislauf- u. Lungendiagnostik)	Bad Arolsen
Germany	Evangelisches Krankenhaus Bad Dürkheim, Innere Medizin	Bad Dürkheim
Germany	Hochtaunus-Kliniken, Medizinische Klinik III	Bad Homburg
Germany	Lungenklinik Ballenstedt/Harz gGmbH, Ev. Fachkrankenhaus f. Lungenkrankheiten	Ballenstedt
Germany	Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie	Berlin
Germany	Charité - Universitätsmedizin Berlin, Zentrum Anästhesiologie und Intensivmedizin	Berlin
Germany	Evangelisches Geriatriezentrum Berlin	Berlin
Germany	Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie	Berlin
Germany	HELIOS Klinikum Berlin-Buch, Interdisziplinäres Notfallzentrum mit Rettungsstelle	Berlin
Germany	Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin	Berlin
Germany	Vivantes Klinikum Spandau, Kard., Pneum. und kons. Intensivmedizin	Berlin
Germany	Vivantes Netzwerk f. Gesundheit GmbH Vivantes Klinikum Neukölln, Klinik f. Innere Med. - Pneumologie u.Infektiologie - Thoraxzentrum	Berlin
Germany	Berufsgenossenschaftl. Universitätsklinikum Bergmannsheil GmbH, Klinik f. Pneumologie, Allergologie u. Schlafmedizin	Bochum
Germany	Evangelische Kliniken Bonn, Betriebsstätte Johanniter Krankenhaus, Innere Medizin II	Bonn
Germany	Med. Klinik d. Forschungszentrum Borstel, Fachkrankenhaus f. Lungenerkrankungen, Infektionen u. Allergien	Borstel
Germany	Städt. Klinikum Dessau, Innere Medizin	Dessau-Roßlau
Germany	Klinikum Dortmund gGmbH, Medizinische Klinik (Pneumologie / Infektiologie)	Dortmund
Germany	Knappschaftskrankenhaus Dortmund, Klinik für Pneumologie	Dortmund
Germany	Universitätsklinikum Carl Gustav Carus, TU Dresden, Medizinische Klinik 1 - Abteilung Pneumologie	Dresden
Germany	SRH Wald-Klinikum Gera gGmbH, Medizinische Klinik 2	Gera
Germany	Uniklinikum Greifswald, Zentrum für Innere Medizin B	Greifswald
Germany	Krankenhaus Martha-Maria Halle-Dölau, Klinik für Innere Medizin I	Halle (Saale)
Germany	Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III (Kardiologie, Pneumologie, Intensivmedizin, Angiologie)	Halle (Saale)
Germany	ASKLEPIOS Klinik Wandsbek, 1. Medizinische Abteilung	Hamburg
Germany	Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale	Hamburg
Germany	Medizinische Hochschule Hannover, Klinik für Pneumologie	Hannover
Germany	Klinkum Heidenheim, Medizinische Klinik II & Innere Intensiv	Heidenheim
Germany	Kliniken d. Main-Taunus-Kreises, Klinik f. Pneumologie u. Allg. Innere Medizin	Hofheim
Germany	Universitätsklinikum des Saarlandes, Innere Medizin V	Homburg/Saar
Germany	Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivtherapie	Jena
Germany	Universitätsklinikum Jena, Zentrum für Infektionsmedizin und Krankenhaushygiene, Studienabteilung	Jena
Germany	St.Vincentius-Kliniken gAG, Med. Klinik IV / Pneumologie	Karlsruhe
Germany	Universitätsklinikum Schleswig-Holstein - Campus Kiel, Medizin 1	Kiel
Germany	Evangelisches Krankenhaus Kalk gGmbH, Innere Medizin / Pneumologie	Köln
Germany	Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie	Leipzig
Germany	Universität Leipzig, Innere Medizin, Neurologie und Dermatologie, Pneumologie / Studiensekretariat	Leipzig
Germany	Franziskus Krankenhaus Linz, Innere Abteilung	Linz
Germany	Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Med. Klinik III (Pneumologie)	Lübeck
Germany	St. Vincenz und Elisabeth Hospital Mainz, Innere Medizin	Mainz
Germany	Universitätsmedizin Mannheim, Studienkoordinierungszentrum, 1. Medizinische Klinik	Mannheim
Germany	Krankenhaus München-Neuperlach, Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin	München
Germany	Städtisches Klinikum München GmbH - Klinikum Harlaching, Klinik für Gastroent., Pneum., intern. Akut- u. Intensivmedizin	München
Germany	Universitätsklinikum Münster, Kardiologie 1	Münster
Germany	Dietrich-Bonhoeffer-Klinikum, Klinik f. Innere Medizin 2 (Abt. Pulmologie)	Neubrandenburg
Germany	Ev. Fachkrankenhaus für Atemwegserkrankungen	Neustadt
Germany	Pius-Hospital Oldenburg, Klinik f. Innere Med., Abt. f. Pneumologie	Oldenburg
Germany	Brüderkrankenhaus St. Josef, Medizinische Klinik	Paderborn
Germany	Christliches Krankenhaus Quakenbrück e. V., Med. Klinik (Abtl. Pneumologie, Allergologie, Schlafmedizin)	Quakenbrück
Germany	Universitätsklinikum Regensburg, Klinik Innere Medizin I, Intensivmedizin, Endokrinologie	Regensburg
Germany	Mathias-Spital Rheine, Klinik für Pneumologie und Thoraxonkologie	Rheine
Germany	Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie	Rotenburg/Wümme
Germany	Altmark-Klinikum gGmbH, Krankenhaus Salzwedel	Salzwedel
Germany	HELIOS Kliniken Schwerin GmbH, Klinik für Internistische und Neurologische Intensivmedizin/Stroke Unit	Schwerin
Germany	Krankenhaus Bethanien gGmbH Solingen, Abt. Pneumologie	Solingen
Germany	Kreisklinik Trostberg, Innere Abteilung	Trostberg
Germany	Universitätsklinikum Ulm, Klinik für Innere Medizin II, Sudienzentrale Innere II, Sektion Pneumologie	Ulm
Germany	HELIOS Klinikum Wuppertal, Klinik für Intensivmedizin	Wuppertal
Germany	HELIOS Klinikum Wuppertal, Pneumologie, Bergisches Lungenzentrum	Wuppertal
Germany	Missionsärztliche Klinik GmbH Würzburg, Innere Medizin (Pneumologie)	Würzburg

Sponsors (7)

Lead Sponsor	Collaborator
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps	Charite University, Berlin, Germany, German Federal Ministry of Education and Research, Jena University Hospital, University Medicine Greifswald, University of Giessen, University of Leipzig

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst measure of disease severity	Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).	Between enrollment and day six
Secondary	All cause mortality		up to one year after enrolment
Secondary	disease-specific mortality		up to one year after enrolment
Secondary	duration of hospitalization		up to one year after enrolment
Secondary	duration of intensive care treatment		up to one year after enrolment
Secondary	duration of ventilator assisted breathing		up to one year after enrolment

External Links

•   Study portal for access to electronic case report form (eCRF)
•   Study website in the portal of the Network of excellence in Community Acquired Pneumonia (CAPNETZ)