NCT05688774 Study of Progression of Community Acquired Pneumonia in the Hospital in Patients With More Severe Preexisting Diseases and Immunosuppression
| NCT ID | NCT05688774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps |
| Condition | Pneumonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-02-28 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-02-28 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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: 1. Hospitalization with community acquired pneumonia (CAP) confirmed by pulmonary infiltrate in chest imaging 2. Valid informed consent form 3. Working diagnosis of CAP by enrolling physician 4. No hospitalization for any reason within 28 days prior to hospitalization for the current episode of CAP 5. 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 6. 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 Criteria: 1. Participation in this study at an earlier time 2. More than 48 hours in the hospital before enrollment (for patients directly to intensive care: more than 7 days) 3. Pregnancy 4. Breastfeeding 5. Active tuberculosis 6. Acute lung injury or acute respiratory distress syndrome for extrapulmonary reasons 7. Massive aspiration 8. Sepsis with extrapulmonary focus 9. Acute pulmonary embolism
Contact & Investigator
Norbert Suttorp, MD
PRINCIPAL INVESTIGATOR
Charité Univerity, Berlin, Germany
Frequently Asked Questions
Who can join the NCT05688774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05688774 currently recruiting?
Yes, NCT05688774 is actively recruiting participants. Contact the research team at sarah.berger@charite.de for enrollment information.
Where is the NCT05688774 trial being conducted?
This trial is being conducted at Berlin, Germany, Berlin, Germany, Berlin, Germany, Dessau, Germany and 6 additional locations.
Who is sponsoring the NCT05688774 clinical trial?
NCT05688774 is sponsored by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps. The principal investigator is Norbert Suttorp, MD at Charité Univerity, Berlin, Germany. The trial plans to enroll 300 participants.