Pneumonia Clinical Trial in Paderborn
NCT02782013
| Observational
This study has recruited 2309 Participants
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.
Details for the study
Population
Adult patients hospitalized for treatment of community acquired pneumonia. Patients can be
enrolled in general care, intensive care, and in emergency departments.
Brief Title
Study of Progression of Community Acquired Pneumonia in the Hospital
Official Title
Study of Progression of Hospitalized Community Acquired Pneumonia - Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis
Brief Summary
Pneumonia is a common infectious disease of the lung, often requiring treatment in the
<br /> hospital. Clinical scoring systems are available, identifying patients not requiring
<br /> hospitalization. However, the course of disease of patients in the hospital remains hard to
<br /> predict. While most patients will recover quickly, some will, despite appropriate treatment,
<br /> develop a severe course leading to sepsis and systemic responses resulting in organ
<br /> dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular
<br /> markers and combinations thereof predicting a severe course of pneumonia in the hospital.
<br /> Such predictors will, for instance, support decisions on earlier transfer of patients to
<br /> 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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Worst measure of disease severity
Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).
Study 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