Study of Progression of Community Acquired Pneumonia in the Hospital in Patients With More Severe Preexisting Diseases and Immunosuppression

NCT05688774 | Recruiting

• 1 other identifier: PROGRESS-COMORB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

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.

Conditions

Pneumonia; Sepsis; Shock, Septic

Keywords

community ascquired pneumonia; CAP; disease progression

Outcome Measures

Primary Outcomes (1)

• Worst measure of disease severity

  Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).

  Between enrollment and day six

Secondary Outcomes (5)

• All cause mortality

  up to one year after enrollment

• disease-specific mortality

  up to one year after enrollment

• duration of hospitalization

  up to one year after enrollment

• duration of intensive care treatment

  up to one year after enrollment

• duration of ventilator assisted breathing

  up to one year after enrollment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients hospitalized for treatment of community acquired pneumonia. Patients can be enrolled in general care, intensive care, and in emergency departments.

You may qualify if:

• Hospitalization with community acquired pneumonia (CAP) confirmed by pulmonary infiltrate in chest imaging
• Valid informed consent form
• Working diagnosis of CAP by enrolling physician
• No hospitalization for any reason within 28 days prior to hospitalization for the current episode of CAP
• 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
• 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

You may not qualify if:

• Participation in this study at an earlier time
• More than 48 hours in the hospital before enrollment (for patients directly to intensive care: more than 7 days)
• Pregnancy
• Breastfeeding
• Active tuberculosis
• Acute lung injury or acute respiratory distress syndrome for extrapulmonary reasons
• Massive aspiration
• Sepsis with extrapulmonary focus
• Acute pulmonary embolism

Sponsors & Collaborators

• Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps: lead
• Charite University, Berlin, Germany: collaborator
• University of Leipzig: collaborator
• Jena University Hospital: collaborator

Study Sites (10)

Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie

Berlin, 13353, Germany

RECRUITING

Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin

Berlin, 13509, Germany

RECRUITING

Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie

Berlin, 14089, Germany

RECRUITING

Städtisches Klinikum Dessau, Innere Medizin

Dessau, 06847, Germany

RECRUITING

Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale

Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Leipzig, Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie

Leipzig, 04103, Germany

RECRUITING

Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie

Leipzig, 04129, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg, Klinik für Pneumologie und Anästhesie

Marburg, 35043, Germany

RECRUITING

Universitätsklinikum Münster, Kardiologie 1

Münster, 48149, Germany

RECRUITING

Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie

Rotenburg (Wümme), 27356, Germany

WITHDRAWN

Biospecimen

Retention: SAMPLES WITH DNA

DNA from EDTA whole blood, RNA from stabilized whole blood, serum, citrate plasma, stabilized EDTA plasma, urin

MeSH Terms

Conditions

Pneumonia; Sepsis; Shock, Septic; Disease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Norbert Suttorp, MD

  Charité Univerity, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Berger, MD

CONTACT

+49-30-450553347; sarah.berger@charite.de

Peter Ahnert, MD

CONTACT

+49-341-9716282; peter.ahnert@imise.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: February 28, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (10)