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 : September 25, 2017
|Condition or disease|
|Pneumonia Sepsis Shock, Septic|
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 Type :||Observational|
|Estimated Enrollment :||3000 participants|
|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|
- Worst measure of disease severity [ Time Frame: Between enrollment and day six ]Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).
- All cause mortality [ Time Frame: up to one year after enrolment ]
- disease-specific mortality [ Time Frame: up to one year after enrolment ]
- duration of hospitalization [ Time Frame: up to one year after enrolment ]
- duration of intensive care treatment [ Time Frame: up to one year after enrolment ]
- duration of ventilator assisted breathing [ Time Frame: up to one year after enrolment ]
Biospecimen Retention: Samples With DNA
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
|Contact: Petra Creutz, MDemail@example.com|
|Contact: Peter Ahnert, PhDfirstname.lastname@example.org|
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|Principal Investigator:||Norbert Suttorp, MD||Charite University, Berlin, Germany|