PneumoniaPROGRESSCOMORBNCT05688774
Study of Progression of Community Acquired Pneumonia in the Hospital in Patients With More Severe Preexisting Diseases and Immunosuppression
An observational study of Pneumonia and Sepsis, run by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pneumonia, Sepsis, Shock, Septic
- How many people
- 300 participants
- Where
- 10 sitesGermany
- Study dates
- 28 Feb 2022to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized for treatment of community acquired pneumonia. Patients can be enrolled in general care, intensive care, and in emergency departments.
Who may be able to join
- 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
Show all 25Show fewer
- 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
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Massive aspiration
- Sepsis with extrapulmonary focus
- Acute pulmonary embolism
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Germany10 sites, 9 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Medizinische Klinik m. S. Infektiologie und Pneumologie
Berlin, 13353
- Recruiting
Humboldt-Klinikum Vivantes, Kardiologie und kons. Intensivmedizin
Berlin, 13509
- Recruiting
Gemeinschaftskrankenhaus Havelhöhe, Kardio-Pneumologie
Berlin, 14089
- Recruiting
Städtisches Klinikum Dessau, Innere Medizin
Dessau, 06847
- Recruiting
Universitätsklinikum Hamburg Eppendorf, Onkologisches Zentrum, Pneumologische Studienzentrale
Hamburg, 20246
- Recruiting
Universitätsklinikum Leipzig, Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie
Leipzig, 04103
- Recruiting
Klinikum St. Georg gGmbH, Klinik für Infektions-/Tropenmedizin und Nephrologie
Leipzig, 04129
- Recruiting
Universitätsklinikum Gießen und Marburg, Klinik für Pneumologie und Anästhesie
Marburg, 35043
- Recruiting
Universitätsklinikum Münster, Kardiologie 1
Münster, 48149
- Withdrawn
Diakoniekrankenhaus Rotenburg(Wümme)gGmbH, Zentrum für Pneumologie
Rotenburg (Wümme), 27356
About this study
Official title: 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
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.
Read the detailed description
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 recover quickly, others 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.
In this observational, longitudinal case-cohort study, patients are enrolled within 48 hours of hospitalization (within 7 days for patients directly admitted to intensive care) and patient's progress is followed in much detail for up to six days thereafter. Further data are collected until discharge from the hospital. Patients are followed up on at days 28, 180, and 360 after enrollment.
Baseline assessment comprises sociodemographic, anamnestic, family history, and life-style information. Upon enrollment, Pneumonia Severity Index (PSI) and CURB-65 are determined. For the day of enrollment, up to six subsequent study days routine laboratory and clinical observations and information on therapy are documented as well as data for determining the Sequential Organ Failure Assessment (SOFA) score, Systemic Inflammatory Response Syndrome (SIRS) status, and organ dysfunction. Starting with enrollment, up to four consecutive sets of biomaterials are collected comprising serum, plasma, and materials for extraction of RNA. Blood for extraction of DNA is collected once.
Follow up comprises vital status, housing situation, recurrence of pneumonia, stroke, myocardial infarction, occurrence of diabetes and a quality of life questionnaire.
In the PROGRESS consortium, the transition (progression) from uncomplicated community-acquired pneumonia acquired pneumonia (uCAP) to severe CAP (sCAP) to CAP with severe sepsis or septic shock or multiple organ failure (ssCAP) is investigated. Previous work of the PROGRESS consortium led to the successful identification of an operationalization for the severity of CAP and causal pathomechanistic correlations, a clinical prognosis score, the assignment of altered molecules to dysfunctions of the respiratory tract, kidneys, coagulation, cardiovascular system, and liver, and a gene expression signature for early detection of patients at risk of developing ssCAP.
For the translation of findings from the PROGRESS-CAP study into clinical applicability, their applicability to CAP patients with immunosuppression or with more severe preexisting conditions has to be confirmed.
- Conditions
- Pneumonia, Sepsis, Shock, Septic
- Keywords
- community ascquired pneumonia, CAP, disease progression
- Medical subject headings
- Pneumonia, Sepsis, Shock, Septic, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst measure of disease severity
Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).
Measured: Between enrollment and day six
Secondary outcomes (5)
All cause mortality
Measured: up to one year after enrollment
disease-specific mortality
Measured: up to one year after enrollment
duration of hospitalization
Measured: up to one year after enrollment
duration of intensive care treatment
Measured: up to one year after enrollment
duration of ventilator assisted breathing
Measured: up to one year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start28 Feb 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Leipzig, Jena University Hospital
- Responsible party
- Sponsor
- Investigators
- Norbert Suttorp, MD, Principal investigator, Charité Univerity, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688774
- Sponsor's protocol ID
- PROGRESS-COMORB
- Acronym
- PROGRESSCOMORB
- Status last verified
- Mar 2024
- First submitted
- 9 Jan 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data will be made available after conclusion of the study. Participants can apply for clinical and molecular study data by sending structured project proposals to the PROGRESS board. The PROGRESS board will evaluate proposals for scientific quality, adherence to the limits set by patient's informed consent statements and by intellectual property regulations of the funding agency. Proposals shall not be denied without concrete reason.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05688774
- Acronym / sponsor ID
- PROGRESSCOMORB / PROGRESS-COMORB
- Conditions
- Pneumonia, Sepsis, Shock, Septic
- Keywords
- community ascquired pneumonia, CAP, disease progression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe SepsUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Leipzig, Jena University Hospital
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 recover quickly, others 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.
In this observational, longitudinal case-cohort study, patients are enrolled within 48 hours of hospitalization (within 7 days for patients directly admitted to intensive care) and patient's progress is followed in much detail for up to six days thereafter. Further data are collected until discharge from the hospital. Patients are followed up on at days 28, 180, and 360 after enrollment.
Baseline assessment comprises sociodemographic, anamnestic, family history, and life-style information. Upon enrollment, Pneumonia Severity Index (PSI) and CURB-65 are determined. For the day of enrollment, up to six subsequent study days routine laboratory and clinical observations and information on therapy are documented as well as data for determining the Sequential Organ Failure Assessment (SOFA) score, Systemic Inflammatory Response Syndrome (SIRS) status, and organ dysfunction. Starting with enrollment, up to four consecutive sets of biomaterials are collected comprising serum, plasma, and materials for extraction of RNA. Blood for extraction of DNA is collected once.
Follow up comprises vital status, housing situation, recurrence of pneumonia, stroke, myocardial infarction, occurrence of diabetes and a quality of life questionnaire.
In the PROGRESS consortium, the transition (progression) from uncomplicated community-acquired pneumonia acquired pneumonia (uCAP) to severe CAP (sCAP) to CAP with severe sepsis or septic shock or multiple organ failure (ssCAP) is investigated. Previous work of the PROGRESS consortium led to the successful identification of an operationalization for the severity of CAP and causal pathomechanistic correlations, a clinical prognosis score, the assignment of altered molecules to dysfunctions of the respiratory tract, kidneys, coagulation, cardiovascular system, and liver, and a gene expression signature for early detection of patients at risk of developing ssCAP.
For the translation of findings from the PROGRESS-CAP study into clinical applicability, their applicability to CAP patients with immunosuppression or with more severe preexisting conditions has to be confirmed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized for treatment of community acquired pneumonia. Patients can be enrolled in general care, intensive care, and in emergency departments.
Key inclusion criteria (25 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Worst measure of disease severity
Time frame: Between enrollment and day six
Disease severity is operationalized by the Sequential Organ Failure Assessment (SOFA-score).
5 secondary outcomes
All cause mortality
Time frame: up to one year after enrollment
disease-specific mortality
Time frame: up to one year after enrollment
duration of hospitalization
Time frame: up to one year after enrollment
duration of intensive care treatment
Time frame: up to one year after enrollment
duration of ventilator assisted breathing
Time frame: up to one year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data will be made available after conclusion of the study. Participants can apply for clinical and molecular study data by sending structured project proposals to the PROGRESS board. The PROGRESS board will evaluate proposals for scientific quality, adherence to the limits set by patient's informed consent statements and by intellectual property regulations of the funding agency. Proposals shall not be denied without concrete reason.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norbert Suttorp, MD principal investigator
Charité Univerity, Berlin, Germany
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Sepsis, run by Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Seps at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Berger, MD (+49-30-450553347, sarah.berger@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst measure of disease severity (time frame: Between enrollment and day six). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.