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Recruiting
NCT05688774
Study of Progression of Community Acquired Pneumonia in the Hospital in Patients With More Severe Preexisting Diseases and Immunosuppression
Conditions: Pneumonia, Sepsis, Shock, Septic
Sex: All
Ages: 18 Years – 99 Years
Enrollment: 300
Sponsor: Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
Location: Germany
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 Criteria
Inclusion Criteria:Hospitalization with community acquired pneumonia (CAP) confirmed by pulmonary infiltrate in chest imagingValid informed consent formWorking diagnosis of CAP by enrolling physicianNo hospitalization for any reason within 28 days prior to hospitalization for the current episode of CAPAt least 2 out of the five following clinical symptoms:FeverCoughPurulent sputumShortness of breath or need for respiratory supportCrackling or rales on auscultation, dullness to percussion, or bronchial breathingAt least 1 of the following criteriaKnown HIV infection or AIDSAnti-tumor treatment within the past six monthsTherapy with corticosteroids ≥ 20mg for ≥ 14 days before enrollmentNon-steroidal immunosuppressive therapy within the past six monthsCytostatic therapy within the past six monthsRadiation therapy within the past six monthsBone marrow transplant receivedRespiratory support at home via tracheostomaCystic fibrosisCongestive heart failure New York Heart Association (NYHA) IV stadiumLiver insufficiency Child-Pugh C stadiumExclusion Criteria:Participation in this study at an earlier timeMore than 48 hours in the hospital before enrollment (for patients directly to intensive care: more than 7 days)PregnancyBreastfeedingPost-stenotic pneumonia in conjunction with bronchial carcinomaActive tuberculosisAcute lung injury or acute respiratory distress syndrome for extrapulmonary reasonsMassive aspirationSepsis with extrapulmonary focusAcute pulmonary embolism
Source: ClinicalTrials.gov (NCT05688774). StuddyBuddy aggregates publicly available trial information.