Study of Progression of Community Acquired Pneumonia in the Hospital in Patients With More Severe Preexisting Diseases and Immunosuppression
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
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
300 participants
Feb 28, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria25
- 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)
Exclusion Criteria9
- Participation in this study at an earlier time
- More than 48 hours in the hospital before enrollment (for patients directly to intensive care: more than 7 days)
- Pregnancy
- Breastfeeding
- Active tuberculosis
- Acute lung injury or acute respiratory distress syndrome for extrapulmonary reasons
- Massive aspiration
- Sepsis with extrapulmonary focus
- Acute pulmonary embolism
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Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05688774