Study of Progression of Hospitalized Community Acquired Pneumonia - Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis in Patients With More Severe Preexisting Diseases and Immunosuppression to Complement the PROGRESS CAP Cohort

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
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 consortium aims to identify clinical, genetic, and other molecular markers and combinations there of 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. PROGRESS-COMORB aims to extend findings from the previous PROGRESS study to patients with more severe preexisting conditions and immunosuppression.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Hospitalization with community acquired pneumonia (CAP) confirmed by pulmonary infiltrate in chest imaging

• Valid informed consent form

• Working diagnosis of CAP by enrolling physician

• No hospitalization for any reason within 28 days prior to hospitalization for the current episode of CAP

• 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

• At least 1 of the following criteria

‣ Known HIV infection or AIDS

⁃ Anti-tumor treatment within the past six months

⁃ 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

⁃ Heart failure: New York Heart Association (NYHA) Stadium IV or HFrEF (defined as left ventricular ejection fraction \<40%).

⁃ Decompensated liver disease (Child-Pugh class C)

⁃ Diabetes mellitus with HbA1c ≥ 8,5 %

⁃ End-stage renal disease requiring dialysis

⁃ Pulmonary hypertension (all classes) with mPAP \> 20 mmHg (right heart catheter)

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie
RECRUITING
Berlin
Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie
RECRUITING
Berlin
Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin
RECRUITING
Berlin
Städtisches Klinikum Dessau, Innere Medizin
RECRUITING
Dessau
Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale
RECRUITING
Hamburg
Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie
RECRUITING
Leipzig
Universitätsklinikum Leipzig, Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie
RECRUITING
Leipzig
Universitätsklinikum Gießen und Marburg, Klinik für Pneumologie und Anästhesie
RECRUITING
Marburg
Universitätsklinikum Münster, Kardiologie 1
RECRUITING
Münster
Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie
WITHDRAWN
Rotenburg (wümme)
Contact Information
Primary
Sarah Berger, MD
sarah.berger@charite.de
+49-30-450553347
Backup
Peter Ahnert, MD
peter.ahnert@imise.uni-leipzig.de
+49-341-9716282
Time Frame
Start Date: 2022-02-28
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 300
Related Therapeutic Areas
Sponsors
Collaborators: Jena University Hospital, University of Leipzig, Charite University, Berlin, Germany
Leads: Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps

This content was sourced from clinicaltrials.gov