Understanding pneumonia progression in hospitalized patients with severe preexisting conditions
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
This study is tracking how pneumonia affects hospitalized patients with serious health issues to see if certain signs can help predict their recovery and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps Academic / other |
| Drugs / interventions | Radiation |
| Locations | 10 sites (Berlin and 9 other locations) |
| Trial ID | NCT05688774 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track the progression of community-acquired pneumonia (CAP) in hospitalized patients who have severe preexisting diseases and are immunosuppressed. Patients will be enrolled within 48 hours of hospitalization, and their clinical progress will be monitored for up to six days, with follow-ups at 28, 180, and 360 days post-enrollment. The study seeks to identify clinical, genetic, and molecular markers that can predict severe outcomes, such as sepsis, to improve patient management and outcomes. By extending findings from previous research, this study focuses on a vulnerable population that may require more intensive care.
Who should consider this trial
Good fit: Ideal candidates include hospitalized patients diagnosed with community-acquired pneumonia who have severe preexisting conditions or are immunosuppressed.
Not a fit: Patients without severe preexisting conditions or those not hospitalized for pneumonia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of severe pneumonia in at-risk patients, potentially reducing mortality and morbidity.
How similar studies have performed: Previous studies have shown promise in identifying predictors of severe pneumonia outcomes, but this specific focus on immunosuppressed patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin and 9 other locations
- Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie — Berlin, Germany (Recruiting)
- Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin — Berlin, Germany (Recruiting)
- Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie — Berlin, Germany (Recruiting)
- Städtisches Klinikum Dessau, Innere Medizin — Dessau, Germany (Recruiting)
- Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale — Hamburg, Germany (Recruiting)
- Universitätsklinikum Leipzig, Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie — Leipzig, Germany (Recruiting)
- Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie — Leipzig, Germany (Recruiting)
- Universitätsklinikum Gießen und Marburg, Klinik für Pneumologie und Anästhesie — Marburg, Germany (Recruiting)
- Universitätsklinikum Münster, Kardiologie 1 — Münster, Germany (Recruiting)
- Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie — Rotenburg (Wümme), Germany (Withdrawn)
Study contacts
- Principal investigator: Norbert Suttorp, MD — Charité Univerity, Berlin, Germany
- Study coordinator: Sarah Berger, MD
- Email: sarah.berger@charite.de
- Phone: +49-30-450553347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.