Understanding pneumonia progression in hospitalized patients with severe preexisting conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.