Actively Recruiting
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
Led by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps · Updated on 2024-03-13
300
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
Lead Sponsor
C
Charite University, Berlin, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pneumonia is a common lung infection often requiring hospital treatment, but predicting the disease course in hospitalized patients remains challenging. While most recover quickly, some develop severe complications like sepsis and organ failure despite treatment. The PROGRESS consortium is studying clinical, genetic, and molecular markers to predict severe pneumonia progression, aiming to improve decisions about intensive care transfer. The PROGRESS-COMORB study extends this research to patients with more serious preexisting conditions and weakened immune systems. This observational, longitudinal study enrolls patients within 48 hours of hospitalization (or within 7 days if admitted directly to intensive care) and follows their progress closely for up to six days. Baseline assessments include demographic, medical history, and lifestyle data. Clinical scores like the Pneumonia Severity Index and CURB-65 are recorded. Daily lab tests, clinical observations, and therapy details are collected, alongside biomaterial samples for genetic and molecular analysis. Follow-up visits occur at 28, 180, and 360 days after enrollment. Participants undergo ongoing evaluations including vital status, housing situation, pneumonia recurrence, and quality of life assessments. Researchers track disease severity using measures like the Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome status. The primary outcome is the worst disease severity recorded between enrollment and day six. Secondary outcomes include mortality, hospitalization duration, time in intensive care, and ventilator use up to one year after enrollment. The study involves detailed monitoring to better understand pneumonia progression in patients with complex health issues.
CONDITIONS
Brief Title
Study of Progression of Community Acquired Pneumonia in the Hospital in Patients With More Severe Preexisting Diseases and Immunosuppression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized with community acquired pneumonia confirmed by chest imaging
- Provide valid informed consent
- Working diagnosis of community acquired pneumonia by enrolling physician
- No hospitalization for any reason within 28 days prior to current pneumonia hospitalization
- At least two of the following symptoms: fever, cough, purulent sputum, shortness of breath or need for respiratory support, abnormal lung sounds
- At least one of the following: HIV infection or AIDS, anti-tumor treatment within past six months, corticosteroid therapy ≥ 20mg for ≥ 14 days, non-steroidal immunosuppressive therapy within past six months, cytostatic therapy within past six months, radiation therapy within past six months, bone marrow transplant, home respiratory support via tracheostoma, cystic fibrosis, severe heart failure (NYHA IV or HFrEF <40%), decompensated liver disease (Child-Pugh C), diabetes with HbA1c ≥ 8.5%, end-stage renal disease requiring dialysis, pulmonary hypertension with mPAP > 20 mmHg
You will not qualify if you...
- Previously participated in this study
- More than 48 hours in hospital before enrollment (or more than 7 days if admitted directly to intensive care)
- Pregnancy
- Breastfeeding
- Active tuberculosis
- Acute lung injury or respiratory distress syndrome from causes other than pneumonia
- Massive aspiration
- Sepsis with infection source outside the lungs
- Acute pulmonary embolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 48 hours after hospitalization (or up to 7 days if admitted directly to intensive care)
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 6 days following enrollment
Participants are closely monitored for disease progression with routine laboratory, clinical observations, and therapy documentation, including assessments of disease severity and organ function.
Daily visits or assessments for up to 6 days
Duration - Until hospital discharge after monitoring period
Participants continue to be observed for clinical outcomes and hospital course until discharge from the hospital.
Duration varies depending on hospital stay; assessments occur as part of routine care
Duration - Up to one year after enrollment
Participants are followed up to assess vital status, health conditions, and quality of life after hospital discharge.
Follow-up visits or contacts at days 28, 180, and 360 after enrollment
Trial Site Locations
Total: 10 locations
1
Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie
Berlin, Germany, 13353
Actively Recruiting
2
Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin
Berlin, Germany, 13509
Actively Recruiting
3
Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie
Berlin, Germany, 14089
Actively Recruiting
4
Städtisches Klinikum Dessau, Innere Medizin
Dessau, Germany, 06847
Actively Recruiting
5
Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale
Hamburg, Germany, 20246
Actively Recruiting
6
Universitätsklinikum Leipzig, Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie
Leipzig, Germany, 04103
Actively Recruiting
7
Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie
Leipzig, Germany, 04129
Actively Recruiting
8
Universitätsklinikum Gießen und Marburg, Klinik für Pneumologie und Anästhesie
Marburg, Germany, 35043
Actively Recruiting
9
Universitätsklinikum Münster, Kardiologie 1
Münster, Germany, 48149
Actively Recruiting
10
Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie
Rotenburg (Wümme), Germany, 27356
Withdrawn
Research Team
S
Sarah Berger, MD
P
Peter Ahnert, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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