Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02782013
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2016-05-19
Brief Title:
Study of Progression of Community Acquired Pneumonia in the Hospital
Sponsor:
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
Organization:
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
Study Overview
Official Title:
Study of Progression of Hospitalized Community Acquired Pneumonia - Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGRESS
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 2403-1008 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 patients 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
The PROGRESS study was initially approved by the ethics board of the University Hospital Jena Friedrich-Schiller-University Jena Germany 2403-1008 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None