NCT02782013

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
2 countries

64 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2009

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

12.8 years

First QC Date

May 19, 2016

Last Update Submit

October 14, 2022

Conditions

Keywords

community acquired pneumoniaCAPdisease progression

Outcome Measures

Primary Outcomes (1)

  • Worst measure of disease severity

    Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).

    Between enrollment and day six

Secondary Outcomes (5)

  • All cause mortality

    up to one year after enrolment

  • disease-specific mortality

    up to one year after enrolment

  • duration of hospitalization

    up to one year after enrolment

  • duration of intensive care treatment

    up to one year after enrolment

  • duration of ventilator assisted breathing

    up to one year after enrolment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Hospitalization with community acquired pneumonia (CAP) confirmed by pulmonary infiltrate in chest radiograph
  • Working diagnosis of CAP by enrolling physician
  • Adult patient \>= 18 years of age
  • Valid informed consent form
  • 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

You may not qualify if:

  • Participation in this study at an earlier time
  • Hospitalization for any reason within 28 days prior to hospitalization for the current episode of CAP
  • More than 48 hours in the hospital before enrollment
  • Pregnancy
  • Breastfeeding
  • Decision on limitation of therapy before enrollment
  • Known HIV infection or AIDS
  • Anti-tumor treatment within the past six months
  • Post-stenotic pneumonia in conjunction with bronchial carcinoma
  • Therapy with corticosteroids ≥ 20mg for ≥ 14 days before enrollment
  • Non-steroidal immunosuppressive therapy within the past six months
  • Cytostatic therapy within the past six months
  • Radiation therapy within the past six months
  • Bone marrow transplant received
  • Respiratory support at home via tracheostoma
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (64)

LKH-Univ. Klinikum Graz, UKIM Pulmologie

Graz, 8036, Austria

Location

Allgemeines Krankenhaus der Stadt Linz, Abteilung Lungenheilkunde

Linz, 4021, Austria

Location

Universitätsklinikum Aachen, Med. Klinik I (Pneumologie)

Aachen, 52057, Germany

Location

Evangel. Krankenhausverein, Luisenhospital, Lungenzentrum

Aachen, 52064, Germany

Location

Krankenhaus Angermünde, Klinik f. Innere Medizin / Pneumologie

Angermünde, 16278, Germany

Location

Krankenhaus Bad Arolsen GmbH, Innere Medizin (Herz-, Kreislauf- u. Lungendiagnostik)

Bad Arolsen, 34454, Germany

Location

Evangelisches Krankenhaus Bad Dürkheim, Innere Medizin

Bad Dürkheim, 67098, Germany

Location

Hochtaunus-Kliniken, Medizinische Klinik III

Bad Homburg, 61348, Germany

Location

Lungenklinik Ballenstedt/Harz gGmbH, Ev. Fachkrankenhaus f. Lungenkrankheiten

Ballenstedt, 06493, Germany

Location

Charité - Universitätsmedizin Berlin, Zentrum Anästhesiologie und Intensivmedizin

Berlin, 12203, Germany

Location

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

Berlin, 12351, Germany

Location

HELIOS Klinikum Berlin-Buch, Interdisziplinäres Notfallzentrum mit Rettungsstelle

Berlin, 13125, Germany

Location

Evangelisches Geriatriezentrum Berlin

Berlin, 13347, Germany

Location

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

Berlin, 13353, Germany

Location

Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin

Berlin, 13509, Germany

Location

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

Berlin, 13585, Germany

Location

Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie

Berlin, 14089, Germany

Location

Berufsgenossenschaftl. Universitätsklinikum Bergmannsheil GmbH, Klinik f. Pneumologie, Allergologie u. Schlafmedizin

Bochum, 44789, Germany

Location

Evangelische Kliniken Bonn, Betriebsstätte Johanniter Krankenhaus, Innere Medizin II

Bonn, 53113, Germany

Location

Med. Klinik d. Forschungszentrum Borstel, Fachkrankenhaus f. Lungenerkrankungen, Infektionen u. Allergien

Borstel, 23845, Germany

Location

Evangelisches Krankenhaus Kalk gGmbH, Innere Medizin / Pneumologie

Cologne, 51103, Germany

Location

Städt. Klinikum Dessau, Innere Medizin

Dessau, 06847, Germany

Location

Klinikum Dortmund gGmbH, Medizinische Klinik (Pneumologie / Infektiologie)

Dortmund, 44145, Germany

Location

Knappschaftskrankenhaus Dortmund, Klinik für Pneumologie

Dortmund, 44309, Germany

Location

Universitätsklinikum Carl Gustav Carus, TU Dresden, Medizinische Klinik 1 - Abteilung Pneumologie

Dresden, 01307, Germany

Location

SRH Wald-Klinikum Gera gGmbH, Medizinische Klinik 2

Gera, 07548, Germany

Location

Uniklinikum Greifswald, Zentrum für Innere Medizin B

Greifswald, 17489, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Innere Medizin I

Halle, 06120, Germany

Location

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

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale

Hamburg, 20246, Germany

Location

ASKLEPIOS Klinik Wandsbek, 1. Medizinische Abteilung

Hamburg, 22043, Germany

Location

Medizinische Hochschule Hannover, Klinik für Pneumologie

Hanover, 30652, Germany

Location

Klinkum Heidenheim, Medizinische Klinik II & Innere Intensiv

Heidenheim, 89522, Germany

Location

Kliniken d. Main-Taunus-Kreises, Klinik f. Pneumologie u. Allg. Innere Medizin

Hofheim, 65719, Germany

Location

Universitätsklinikum des Saarlandes, Innere Medizin V

Homburg/Saar, 66421, Germany

Location

Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivtherapie

Jena, 07747, Germany

Location

Universitätsklinikum Jena, Zentrum für Infektionsmedizin und Krankenhaushygiene, Studienabteilung

Jena, 07747, Germany

Location

St.Vincentius-Kliniken gAG, Med. Klinik IV / Pneumologie

Karlsruhe, 76137, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Medizin 1

Kiel, 24105, Germany

Location

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

Leipzig, 04103, Germany

Location

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

Leipzig, 04129, Germany

Location

Franziskus Krankenhaus Linz, Innere Abteilung

Linz, 53545, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Med. Klinik III (Pneumologie)

Lübeck, 23538, Germany

Location

St. Vincenz und Elisabeth Hospital Mainz, Innere Medizin

Mainz, 55130, Germany

Location

Universitätsmedizin Mannheim, Studienkoordinierungszentrum, 1. Medizinische Klinik

Mannheim, 68167, Germany

Location

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

München, 81545, Germany

Location

Krankenhaus München-Neuperlach, Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin

München, 81737, Germany

Location

Universitätsklinikum Münster, Kardiologie 1

Münster, 48149, Germany

Location

Dietrich-Bonhoeffer-Klinikum, Klinik f. Innere Medizin 2 (Abt. Pulmologie)

Neubrandenburg, 17039, Germany

Location

Ev. Fachkrankenhaus für Atemwegserkrankungen

Neustadt, 99762, Germany

Location

Pius-Hospital Oldenburg, Klinik f. Innere Med., Abt. f. Pneumologie

Oldenburg, 26121, Germany

Location

Brüderkrankenhaus St. Josef, Medizinische Klinik

Paderborn, 33098, Germany

Location

Christliches Krankenhaus Quakenbrück e. V., Med. Klinik (Abtl. Pneumologie, Allergologie, Schlafmedizin)

Quakenbrück, 49610, Germany

Location

Universitätsklinikum Regensburg, Klinik Innere Medizin I, Intensivmedizin, Endokrinologie

Regensburg, 93053, Germany

Location

Mathias-Spital Rheine, Klinik für Pneumologie und Thoraxonkologie

Rheine, 48431, Germany

Location

Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie

Rotenburg (Wümme), 27356, Germany

Location

Altmark-Klinikum gGmbH, Krankenhaus Salzwedel

Salzwedel, 29410, Germany

Location

HELIOS Kliniken Schwerin GmbH, Klinik für Internistische und Neurologische Intensivmedizin/Stroke Unit

Schwerin, 19049, Germany

Location

Krankenhaus Bethanien gGmbH Solingen, Abt. Pneumologie

Solingen, 42699, Germany

Location

Kreisklinik Trostberg, Innere Abteilung

Trostberg an der Alz, 83308, Germany

Location

Universitätsklinikum Ulm, Klinik für Innere Medizin II, Sudienzentrale Innere II, Sektion Pneumologie

Ulm, 89081, Germany

Location

HELIOS Klinikum Wuppertal, Klinik für Intensivmedizin

Wuppertal, 42283, Germany

Location

HELIOS Klinikum Wuppertal, Pneumologie, Bergisches Lungenzentrum

Wuppertal, 42283, Germany

Location

Missionsärztliche Klinik GmbH Würzburg, Innere Medizin (Pneumologie)

Würzburg, 97074, Germany

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

DNA from EDTA whole blood, RNA from stabilized whole blood, serum, citrate plasma, stabilized EDTA plasma, urin

MeSH Terms

Conditions

PneumoniaSepsisShock, SepticCommunity-Acquired PneumoniaDisease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockCommunity-Acquired InfectionsDisease Attributes

Study Officials

  • Norbert Suttorp, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 25, 2016

Study Start

August 25, 2009

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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.

Locations