Study of Progression of Community Acquired Pneumonia in the Hospital

NCT ID: NCT02782013

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2309 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-25
• Study Completion Date: 2022-06-01

Brief 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.

Detailed 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.

Conditions

Pneumonia; Sepsis; Shock, Septic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: collaborator

Jena University Hospital

OTHER

Sponsor Role: collaborator

University of Giessen

OTHER

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norbert Suttorp, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

LKH-Univ. Klinikum Graz, UKIM Pulmologie

Graz, , Austria

Allgemeines Krankenhaus der Stadt Linz, Abteilung Lungenheilkunde

Linz, , Austria

Universitätsklinikum Aachen, Med. Klinik I (Pneumologie)

Aachen, , Germany

Evangel. Krankenhausverein, Luisenhospital, Lungenzentrum

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, Zentrum Anästhesiologie und Intensivmedizin

Berlin, , Germany

Vivantes Netzwerk f. Gesundheit GmbH Vivantes Klinikum Neukölln, Klinik f. Innere Med. - Pneumologie u.Infektiologie - Thoraxzentrum

Berlin, , Germany

HELIOS Klinikum Berlin-Buch, Interdisziplinäres Notfallzentrum mit Rettungsstelle

Berlin, , Germany

Evangelisches Geriatriezentrum Berlin

Berlin, , Germany

Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie

Berlin, , Germany

Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin

Berlin, , Germany

Vivantes Klinikum Spandau, Kard., Pneum. und kons. Intensivmedizin

Berlin, , Germany

Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie

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

Evangelisches Krankenhaus Kalk gGmbH, Innere Medizin / Pneumologie

Cologne, , Germany

Städt. Klinikum Dessau, Innere Medizin

Dessau, , 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, , Germany

Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III (Kardiologie, Pneumologie, Intensivmedizin, Angiologie)

Halle, , Germany

Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale

Hamburg, , Germany

ASKLEPIOS Klinik Wandsbek, 1. Medizinische Abteilung

Hamburg, , Germany

Medizinische Hochschule Hannover, Klinik für Pneumologie

Hanover, , 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

Universität Leipzig, Innere Medizin, Neurologie und Dermatologie, Pneumologie / Studiensekretariat

Leipzig, , Germany

Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie

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

Städtisches Klinikum München GmbH - Klinikum Harlaching, Klinik für Gastroent., Pneum., intern. Akut- u. Intensivmedizin

München, , Germany

Krankenhaus München-Neuperlach, Klinik für Kardiologie, Pneumologie und Internistische 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 an der Alz, , 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, , Germany

Countries

Austria; Germany

References

Rosolowski M, Oberle V, Ahnert P, Creutz P, Witzenrath M, Kiehntopf M, Loeffler M, Suttorp N, Scholz M. Dynamics of cytokines, immune cell counts and disease severity in patients with community-acquired pneumonia - Unravelling potential causal relationships. Cytokine. 2020 Dec;136:155263. doi: 10.1016/j.cyto.2020.155263. Epub 2020 Sep 4.

Reference Type: DERIVED

PMID: 32896803 (View on PubMed)

Ahnert P, Creutz P, Horn K, Schwarzenberger F, Kiehntopf M, Hossain H, Bauer M, Brunkhorst FM, Reinhart K, Volker U, Chakraborty T, Witzenrath M, Loffler M, Suttorp N, Scholz M; PROGRESS Study Group. Sequential organ failure assessment score is an excellent operationalization of disease severity of adult patients with hospitalized community acquired pneumonia - results from the prospective observational PROGRESS study. Crit Care. 2019 Apr 4;23(1):110. doi: 10.1186/s13054-019-2316-x.

Reference Type: DERIVED

PMID: 30947753 (View on PubMed)

Ahnert P, Creutz P, Scholz M, Schutte H, Engel C, Hossain H, Chakraborty T, Bauer M, Kiehntopf M, Volker U, Hammerschmidt S, Loeffler M, Suttorp N; PROGRESS study group. PROGRESS - prospective observational study on hospitalized community acquired pneumonia. BMC Pulm Med. 2016 Jul 28;16(1):108. doi: 10.1186/s12890-016-0255-8.

Reference Type: DERIVED

PMID: 27535544 (View on PubMed)

Related Links

http://www.progress-cap.de/

Study portal for access to electronic case report form (eCRF)

http://capnetz.de/html/progress/project

Study website in the portal of the Network of excellence in Community Acquired Pneumonia (CAPNETZ)

Other Identifiers

PROGRESS-CAP

Identifier Type: -

Identifier Source: org_study_id