Study of Progression of Hospitalized Community Acquired Pneumonia - Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,309
- Locations
- 64
- Primary Endpoint
- Worst measure of disease severity
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •Purulent sputum
- •Shortness of breath or need for respiratory support
- •Crackling or rales on auscultation, dullness to percussion, or bronchial breathing
Exclusion Criteria
- •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
- •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
- •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
Outcomes
Primary Outcomes
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 Outcomes
- duration of hospitalization(up to one year after enrolment)
- All cause mortality(up to one year after enrolment)
- disease-specific mortality(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)