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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

Study Description
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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.

Study Design
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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

Groups and Cohorts
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Outcome Measures
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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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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

Locations
Show Show 64 study locations
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
More Information
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Additional Information:
Study portal for access to electronic case report form (eCRF)  This link exits the ClinicalTrials.gov site Study website in the portal of the Network of excellence in Community Acquired Pneumonia (CAPNETZ)  This link exits the ClinicalTrials.gov site

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    
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