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Study of Progression of Community Acquired Pneumonia in the Hospital (PROGRESS)

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ClinicalTrials.gov Identifier: NCT02782013
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
University of Leipzig
Jena University Hospital
University of Giessen
University Medicine Greifswald
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps

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.

Condition or disease
Pneumonia Sepsis Shock, Septic

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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Progression of Hospitalized Community Acquired Pneumonia - Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis
Actual Study Start Date : September 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Sepsis




Primary Outcome Measures :
  1. Worst measure of disease severity [ Time Frame: Between enrollment and day six ]
    Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: up to one year after enrolment ]
  2. disease-specific mortality [ Time Frame: up to one year after enrolment ]
  3. duration of hospitalization [ Time Frame: up to one year after enrolment ]
  4. duration of intensive care treatment [ Time Frame: up to one year after enrolment ]
  5. duration of ventilator assisted breathing [ Time Frame: up to one year after enrolment ]

Biospecimen Retention:   Samples With DNA
DNA from EDTA whole blood, RNA from stabilized whole blood, serum, citrate plasma, stabilized EDTA plasma, urin


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients hospitalized for treatment of community acquired pneumonia. Patients can be enrolled in general care, intensive care, and in emergency departments.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782013


Contacts
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Contact: Petra Creutz, MD +49-30-450665047 petra.creutz@charite.de
Contact: Peter Ahnert, PhD +49-341-9716282 peter.ahnert@imise.uni-leipzig.de

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Locations
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Austria
LKH-Univ. Klinikum Graz, UKIM Pulmologie Recruiting
Graz, Austria, 8036
Allgemeines Krankenhaus der Stadt Linz, Abteilung Lungenheilkunde Completed
Linz, Austria, 4021
Germany
Universitätsklinikum Aachen, Med. Klinik I (Pneumologie) Completed
Aachen, Germany, 52057
Evangel. Krankenhausverein, Luisenhospital, Lungenzentrum Completed
Aachen, Germany, 52064
Krankenhaus Angermünde, Klinik f. Innere Medizin / Pneumologie Completed
Angermünde, Germany, 16278
Krankenhaus Bad Arolsen GmbH, Innere Medizin (Herz-, Kreislauf- u. Lungendiagnostik) Recruiting
Bad Arolsen, Germany, 34454
Evangelisches Krankenhaus Bad Dürkheim, Innere Medizin Completed
Bad Dürkheim, Germany, 67098
Hochtaunus-Kliniken, Medizinische Klinik III Completed
Bad Homburg, Germany, 61348
Lungenklinik Ballenstedt/Harz gGmbH, Ev. Fachkrankenhaus f. Lungenkrankheiten Recruiting
Ballenstedt, Germany, 06493
Charité - Universitätsmedizin Berlin, Zentrum Anästhesiologie und Intensivmedizin Recruiting
Berlin, Germany, 12203
Vivantes Netzwerk f. Gesundheit GmbH Vivantes Klinikum Neukölln, Klinik f. Innere Med. - Pneumologie u.Infektiologie - Thoraxzentrum Recruiting
Berlin, Germany, 12351
HELIOS Klinikum Berlin-Buch, Interdisziplinäres Notfallzentrum mit Rettungsstelle Completed
Berlin, Germany, 13125
Evangelisches Geriatriezentrum Berlin Recruiting
Berlin, Germany, 13347
Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie Recruiting
Berlin, Germany, 13353
Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin Recruiting
Berlin, Germany, 13509
Vivantes Klinikum Spandau, Kard., Pneum. und kons. Intensivmedizin Recruiting
Berlin, Germany, 13585
Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie Recruiting
Berlin, Germany, 14089
Berufsgenossenschaftl. Universitätsklinikum Bergmannsheil GmbH, Klinik f. Pneumologie, Allergologie u. Schlafmedizin Recruiting
Bochum, Germany, 44789
Evangelische Kliniken Bonn, Betriebsstätte Johanniter Krankenhaus, Innere Medizin II Recruiting
Bonn, Germany, 53113
Med. Klinik d. Forschungszentrum Borstel, Fachkrankenhaus f. Lungenerkrankungen, Infektionen u. Allergien Completed
Borstel, Germany, 23845
Städt. Klinikum Dessau, Innere Medizin Recruiting
Dessau-Roßlau, Germany, 06847
Klinikum Dortmund gGmbH, Medizinische Klinik (Pneumologie / Infektiologie) Recruiting
Dortmund, Germany, 44145
Knappschaftskrankenhaus Dortmund, Klinik für Pneumologie Completed
Dortmund, Germany, 44309
Universitätsklinikum Carl Gustav Carus, TU Dresden, Medizinische Klinik 1 - Abteilung Pneumologie Recruiting
Dresden, Germany, 01307
SRH Wald-Klinikum Gera gGmbH, Medizinische Klinik 2 Completed
Gera, Germany, 07548
Uniklinikum Greifswald, Zentrum für Innere Medizin B Completed
Greifswald, Germany, 17489
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Innere Medizin I Completed
Halle (Saale), Germany, 06120
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III (Kardiologie, Pneumologie, Intensivmedizin, Angiologie) Completed
Halle (Saale), Germany, 06120
Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale Recruiting
Hamburg, Germany, 20246
ASKLEPIOS Klinik Wandsbek, 1. Medizinische Abteilung Completed
Hamburg, Germany, 22043
Medizinische Hochschule Hannover, Klinik für Pneumologie Recruiting
Hannover, Germany, 30652
Klinkum Heidenheim, Medizinische Klinik II & Innere Intensiv Recruiting
Heidenheim, Germany, 89522
Kliniken d. Main-Taunus-Kreises, Klinik f. Pneumologie u. Allg. Innere Medizin Completed
Hofheim, Germany, 65719
Universitätsklinikum des Saarlandes, Innere Medizin V Recruiting
Homburg/Saar, Germany, 66421
Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivtherapie Recruiting
Jena, Germany, 07747
Universitätsklinikum Jena, Zentrum für Infektionsmedizin und Krankenhaushygiene, Studienabteilung Recruiting
Jena, Germany, 07747
St.Vincentius-Kliniken gAG, Med. Klinik IV / Pneumologie Recruiting
Karlsruhe, Germany, 76137
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Medizin 1 Recruiting
Kiel, Germany, 24105
Evangelisches Krankenhaus Kalk gGmbH, Innere Medizin / Pneumologie Recruiting
Köln, Germany, 51103
Universität Leipzig, Innere Medizin, Neurologie und Dermatologie, Pneumologie / Studiensekretariat Recruiting
Leipzig, Germany, 04103
Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie Recruiting
Leipzig, Germany, 04129
Franziskus Krankenhaus Linz, Innere Abteilung Completed
Linz, Germany, 53545
Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Med. Klinik III (Pneumologie) Recruiting
Lübeck, Germany, 23538
St. Vincenz und Elisabeth Hospital Mainz, Innere Medizin Completed
Mainz, Germany, 55130
Universitätsmedizin Mannheim, Studienkoordinierungszentrum, 1. Medizinische Klinik Recruiting
Mannheim, Germany, 68167
Städtisches Klinikum München GmbH - Klinikum Harlaching, Klinik für Gastroent., Pneum., intern. Akut- u. Intensivmedizin Completed
München, Germany, 81545
Krankenhaus München-Neuperlach, Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin Recruiting
München, Germany, 81737
Universitätsklinikum Münster, Kardiologie 1 Recruiting
Münster, Germany, 48149
Dietrich-Bonhoeffer-Klinikum, Klinik f. Innere Medizin 2 (Abt. Pulmologie) Completed
Neubrandenburg, Germany, 17039
Ev. Fachkrankenhaus für Atemwegserkrankungen Completed
Neustadt, Germany, 99762
Pius-Hospital Oldenburg, Klinik f. Innere Med., Abt. f. Pneumologie Completed
Oldenburg, Germany, 26121
Brüderkrankenhaus St. Josef, Medizinische Klinik Completed
Paderborn, Germany, 33098
Christliches Krankenhaus Quakenbrück e. V., Med. Klinik (Abtl. Pneumologie, Allergologie, Schlafmedizin) Recruiting
Quakenbrück, Germany, 49610
Universitätsklinikum Regensburg, Klinik Innere Medizin I, Intensivmedizin, Endokrinologie Completed
Regensburg, Germany, 93053
Mathias-Spital Rheine, Klinik für Pneumologie und Thoraxonkologie Recruiting
Rheine, Germany, 48431
Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie Recruiting
Rotenburg/Wümme, Germany, 27356
Altmark-Klinikum gGmbH, Krankenhaus Salzwedel Recruiting
Salzwedel, Germany, 29410
HELIOS Kliniken Schwerin GmbH, Klinik für Internistische und Neurologische Intensivmedizin/Stroke Unit Completed
Schwerin, Germany, 19049
Krankenhaus Bethanien gGmbH Solingen, Abt. Pneumologie Completed
Solingen, Germany, 42699
Kreisklinik Trostberg, Innere Abteilung Completed
Trostberg, Germany, 83308
Universitätsklinikum Ulm, Klinik für Innere Medizin II, Sudienzentrale Innere II, Sektion Pneumologie Completed
Ulm, Germany, 89081
HELIOS Klinikum Wuppertal, Klinik für Intensivmedizin Completed
Wuppertal, Germany, 42283
HELIOS Klinikum Wuppertal, Pneumologie, Bergisches Lungenzentrum Completed
Wuppertal, Germany, 42283
Missionsärztliche Klinik GmbH Würzburg, Innere Medizin (Pneumologie) Recruiting
Würzburg, Germany, 97074
Sponsors and Collaborators
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
University of Leipzig
Jena University Hospital
University of Giessen
University Medicine Greifswald
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Norbert Suttorp, MD Charite University, Berlin, Germany

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
ClinicalTrials.gov Identifier: NCT02782013     History of Changes
Other Study ID Numbers: PROGRESS-CAP
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant data will be made available after conclusion of the study. Participants can apply for clinical and molecular study data by sending structured project proposals to the PROGRESS board. The PROGRESS board will evaluate proposals for scientific quality, adherence to the limits set by patient's informed consent statements and by intellectual property regulations of the funding agency. Proposals shall not be denied without concrete reason.
Keywords provided by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps:
community acquired pneumonia
CAP
disease progression
Additional relevant MeSH terms:
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Sepsis
Shock, Septic
Pneumonia
Disease Progression
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Shock