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PneumoniaPROGRESSNCT02782013

Study of Progression of Community Acquired Pneumonia in the Hospital

An observational study of Pneumonia and Sepsis, run by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps at 64 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Sepsis, Shock, Septic
How many people
2,309 participants
Where
64 sitesin 2 countries
Study dates
25 Aug 2009to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients hospitalized for treatment of community acquired pneumonia. Patients can be enrolled in general care, intensive care, and in emergency departments.

Who may be able to join

  • 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
Show all 10Show fewer
  • Cough
  • Purulent sputum
  • Shortness of breath or need for respiratory support
  • Crackling or rales on auscultation, dullness to percussion, or bronchial breathing

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • Cystic fibrosis
  • Active tuberculosis
  • Acute lung injury or acute respiratory distress syndrome for extrapulmonary reasons
  • Massive aspiration
  • Sepsis with extrapulmonary focus
  • Acute pulmonary embolism
  • Congestive heart failure New York Heart Association (NYHA) IV stadium
  • Liver insufficiency Child-Pugh C stadium

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

Germany62 sites

  • Universitätsklinikum Aachen, Med. Klinik I (Pneumologie)

    Aachen, 52057

  • Evangel. Krankenhausverein, Luisenhospital, Lungenzentrum

    Aachen, 52064

  • Krankenhaus Angermünde, Klinik f. Innere Medizin / Pneumologie

    Angermünde, 16278

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

    Bad Arolsen, 34454

  • Evangelisches Krankenhaus Bad Dürkheim, Innere Medizin

    Bad Dürkheim, 67098

  • Hochtaunus-Kliniken, Medizinische Klinik III

    Bad Homburg, 61348

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

    Ballenstedt, 06493

  • Charité - Universitätsmedizin Berlin, Zentrum Anästhesiologie und Intensivmedizin

    Berlin, 12203

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

    Berlin, 12351

  • HELIOS Klinikum Berlin-Buch, Interdisziplinäres Notfallzentrum mit Rettungsstelle

    Berlin, 13125

  • Evangelisches Geriatriezentrum Berlin

    Berlin, 13347

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

    Berlin, 13353

  • Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin

    Berlin, 13509

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

    Berlin, 13585

  • Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie

    Berlin, 14089

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

    Bochum, 44789

  • Evangelische Kliniken Bonn, Betriebsstätte Johanniter Krankenhaus, Innere Medizin II

    Bonn, 53113

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

    Borstel, 23845

  • Evangelisches Krankenhaus Kalk gGmbH, Innere Medizin / Pneumologie

    Cologne, 51103

  • Städt. Klinikum Dessau, Innere Medizin

    Dessau, 06847

  • Klinikum Dortmund gGmbH, Medizinische Klinik (Pneumologie / Infektiologie)

    Dortmund, 44145

  • Knappschaftskrankenhaus Dortmund, Klinik für Pneumologie

    Dortmund, 44309

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

    Dresden, 01307

  • SRH Wald-Klinikum Gera gGmbH, Medizinische Klinik 2

    Gera, 07548

  • Uniklinikum Greifswald, Zentrum für Innere Medizin B

    Greifswald, 17489

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

    Halle, 06120

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

    Halle, 06120

  • Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale

    Hamburg, 20246

  • ASKLEPIOS Klinik Wandsbek, 1. Medizinische Abteilung

    Hamburg, 22043

  • Medizinische Hochschule Hannover, Klinik für Pneumologie

    Hanover, 30652

  • Altmark-Klinikum gGmbH, Krankenhaus Salzwedel

    Hansestadt Salzwedel, 29410

  • Klinkum Heidenheim, Medizinische Klinik II & Innere Intensiv

    Heidenheim, 89522

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

    Hofheim, 65719

  • Universitätsklinikum des Saarlandes, Innere Medizin V

    Homburg/Saar, 66421

  • Universitätsklinikum Jena, Klinik für Anästhesiologie und Intensivtherapie

    Jena, 07747

  • Universitätsklinikum Jena, Zentrum für Infektionsmedizin und Krankenhaushygiene, Studienabteilung

    Jena, 07747

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

    Karlsruhe, 76137

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel, Medizin 1

    Kiel, 24105

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

    Leipzig, 04103

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

    Leipzig, 04129

  • Franziskus Krankenhaus Linz, Innere Abteilung

    Linz, 53545

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

    Lübeck, 23538

  • St. Vincenz und Elisabeth Hospital Mainz, Innere Medizin

    Mainz, 55130

  • Universitätsmedizin Mannheim, Studienkoordinierungszentrum, 1. Medizinische Klinik

    Mannheim, 68167

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

    München, 81545

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

    München, 81737

  • Universitätsklinikum Münster, Kardiologie 1

    Münster, 48149

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

    Neubrandenburg, 17039

  • Ev. Fachkrankenhaus für Atemwegserkrankungen

    Neustadt, 99762

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

    Oldenburg, 26121

  • Brüderkrankenhaus St. Josef, Medizinische Klinik

    Paderborn, 33098

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

    Quakenbrück, 49610

  • Universitätsklinikum Regensburg, Klinik Innere Medizin I, Intensivmedizin, Endokrinologie

    Regensburg, 93053

  • Mathias-Spital Rheine, Klinik für Pneumologie und Thoraxonkologie

    Rheine, 48431

  • Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie

    Rotenburg (Wümme), 27356

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

    Schwerin, 19049

  • Krankenhaus Bethanien gGmbH Solingen, Abt. Pneumologie

    Solingen, 42699

  • Kreisklinik Trostberg, Innere Abteilung

    Trostberg an der Alz, 83308

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

    Ulm, 89081

  • HELIOS Klinikum Wuppertal, Klinik für Intensivmedizin

    Wuppertal, 42283

  • HELIOS Klinikum Wuppertal, Pneumologie, Bergisches Lungenzentrum

    Wuppertal, 42283

  • Missionsärztliche Klinik GmbH Würzburg, Innere Medizin (Pneumologie)

    Würzburg, 97074

Other trials in Germany

Austria2 sites

  • LKH-Univ. Klinikum Graz, UKIM Pulmologie

    Graz, 8036

  • Allgemeines Krankenhaus der Stadt Linz, Abteilung Lungenheilkunde

    Linz, 4021

Other trials in Austria

About this study

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

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.

Read the 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.

Keywords
community acquired pneumonia, CAP, disease progression
Medical subject headings
Pneumonia, Sepsis, Shock, Septic, Community-Acquired Pneumonia, Disease Progression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Worst measure of disease severity

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

    Measured: Between enrollment and day six

Secondary outcomes (5)

  1. All cause mortality

    Measured: up to one year after enrolment

  2. disease-specific mortality

    Measured: up to one year after enrolment

  3. duration of hospitalization

    Measured: up to one year after enrolment

  4. duration of intensive care treatment

    Measured: up to one year after enrolment

  5. duration of ventilator assisted breathing

    Measured: up to one year after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2016 (estimated)
  2. Study start25 Aug 2009
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02782013
Sponsor's protocol ID
PROGRESS-CAP
Acronym
PROGRESS
Status last verified
Oct 2022
First submitted
19 May 2016
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • Kirsten H, Weis S, Ahnert P, Witzenrath M, Scicluna BP, Krohn K, Rade M, Horn F, Bertram C, Reiche K, Loffler D, Blumert C, Jenner S, Sohn K, Nouailles G, Kiehntopf M, Creutz P, Rosolowski M, Loeffler M, Suttorp N; PROGRESS Study Group; Scholz M, Bauer M. Community-Acquired Pneumonia: Disease Course Prediction With a 5-Gene Signature. CHEST Pulm. 2026 Mar 10;4(2):100256. doi: 10.1016/j.chpulm.2026.100256. eCollection 2026 Jun.

    PubMed 42548383

  • 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.

    PubMed 32896803

  • 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.

    PubMed 30947753

  • 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.

    PubMed 27535544

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia and Sepsis, run by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps at 64 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worst measure of disease severity (time frame: Between enrollment and day six). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02782013, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.

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