Community-acquired PneumoniaFULMISCAPNCT06516601
Fulminant Severe CAP - an Observational Study
An observational study of Community-acquired Pneumonia and Severe Pneumonia, run by University of Trieste at 2 sites in Italy.
Trial summary
Severe community-acquired pneumonia (CAP) represents a major cause of hospital mortality. Among severe CAP cases, some exhibit a rapidly progressive evolution, leading to severe ARDS/acute respiratory failure and septic shock within hours to a few days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Severe Pneumonia, ARDS, Human
- How many people
- 1,460 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Jan 2018to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the consecutive patients hospitalized for severe CAP in 4 hospitals
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Marco Confalonieri
Trieste, TS, 34149
marco confalonieri, MD, +39040399 ext. 4667, mconfalonieri@units.it
Francesco Salton, MD, +393486986287, francesco.salton@gmail.com
- Recruiting
SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina
Trieste, 34126
Francesco Salton, MD, 00390403994667, francesco.salton@asugi.sanita.fvg.it
About this study
Official title: Fulminant Cases Among Severe Community-acquired Pneumonia - an Observational Retrospective Study
Severe community-acquired pneumonia (CAP) represents a major cause of hospital mortality. Among severe CAP cases, some exhibit a rapidly progressive evolution, leading to severe ARDS/acute respiratory failure and septic shock within hours to a few days. This type of pneumonia, known as "fulminant pneumonia," is characterized by its rapid onset and deterioration, often necessitating immediate medical intervention. Despite its severity, the true incidence and optimal treatment for fulminant pneumonia are not well understood. This knowledge gap is due to the lack of attention towards pneumonia as a potential time-dependent illness and the separation of overlapping clinical topics: severe pneumonia, ARDS, and sepsis.
In clinical practice, pneumonia is the most frequent cause of both ARDS and sepsis. However, these conditions are often considered separately, combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia. The COVID-19 pandemic, with its vast number of severe CAP cases in a short period, has highlighted the existence of fulminant pneumonias, underscoring the need for further investigation. Recent randomized clinical trials (RCTs) and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAP/ARDS of bacterial origin.
The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia.
Read the detailed description
A list of consecutive patients with severe CAP from the 5 participating centers from January 2018 to July 2024. Patients recruited for concomitant randomized clinical trials were allowed. Each Center used an early antibiotic policy (<6 hours) in case of sepsis and/or severe pneumonia diagnosis. The use of corticosteroids varied from several reasons (e.g. RCT protocol, internal policy, physician on duty with not restriction to this.
Both COVID and non-COVID patients were recruited if PaO2:FiO2 <300, bilateral community acquired pneumonia, and 2 or more of the following: increased CRP > 99mg/L, respiratory rate>25bpm or signs of respiratory distress, need for respiratory support (CPAP, MV, HFNC), creatinine>1,49mg/dl, ALT>70. Hospital-acquired and Healthcare-acquired pneumonia were excluded. Also, chronic end-stage illness (e..g. metastatic cancers, advanced neuromuscolar disorders, etc) were excluded.
The following patient caractheristics and clinical data were collected at admission: oxygenation state, vital signs, age, type of unit at admission, admission to ICU, length of hospital stay, type and duration of mechanical ventilation (MV), initial and maximal PEEP administered, ALT, WBC, platelets, Haemoglobin, presence of obesity, comorbidities, risk factors (smoking, abuse).
- Conditions
- Community-acquired Pneumonia, Severe Pneumonia, ARDS, Human, Sepsis
- Being tested
- no intervention
- Keywords
- fulminant pneumonia, community acquired pneumonia, ARDS, sepsis, corticosteroids
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Respiratory Distress Syndrome, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study, the patients received corticosteroids according to the physician on duty
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality in hospital
Measured: 2days, 7days, 30days, 60days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start2 Jan 2018
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired 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
- Retrospective
- Enrolment
- 1,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Confalonieri Marco, MD, University of Trieste
- Investigators
- MARCO CONFALONIERI, MD, Principal investigator, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516601
- Sponsor's protocol ID
- CEUR-2024-OS-6
- Acronym
- FULMISCAP
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salton F, Villar J, Mondoni M, Harari S, Salotti A, Ambros A, Alba F, Ferrando C, Munoz T, Soler JA, Perez-Mendez L, Fernandez C, Martinez D, Gasparotto S, Centanni S, Zuccon U, Barbati G, Rocca A, Ruaro B, Confalonieri M, Confalonieri P. Existence and relevance of fulminant severe community-acquired pneumonia. Pneumonia (Nathan). 2025 Nov 5;17(1):26. doi: 10.1186/s41479-025-00180-0.
PubMed 41189033
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fulminant Cases Among Severe Community-acquired Pneumonia - an Observational Retrospective Study
- ClinicalTrials.gov ID
- NCT06516601
- Acronym / sponsor ID
- FULMISCAP / CEUR-2024-OS-6
- Conditions
- Community-acquired Pneumonia, Severe Pneumonia, ARDS, Human, Sepsis
- Keywords
- fulminant pneumonia, community acquired pneumonia, ARDS, sepsis, corticosteroids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,460 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 Jul 2024 (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.
Severe community-acquired pneumonia (CAP) represents a major cause of hospital mortality. Among severe CAP cases, some exhibit a rapidly progressive evolution, leading to severe ARDS/acute respiratory failure and septic shock within hours to a few days. This type of pneumonia, known as "fulminant pneumonia," is characterized by its rapid onset and deterioration, often necessitating immediate medical intervention. Despite its severity, the true incidence and optimal treatment for fulminant pneumonia are not well understood. This knowledge gap is due to the lack of attention towards pneumonia as a potential time-dependent illness and the separation of overlapping clinical topics: severe pneumonia, ARDS, and sepsis.
In clinical practice, pneumonia is the most frequent cause of both ARDS and sepsis. However, these conditions are often considered separately, combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia. The COVID-19 pandemic, with its vast number of severe CAP cases in a short period, has highlighted the existence of fulminant pneumonias, underscoring the need for further investigation. Recent randomized clinical trials (RCTs) and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAP/ARDS of bacterial origin.
The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia.
Detailed description
A list of consecutive patients with severe CAP from the 5 participating centers from January 2018 to July 2024. Patients recruited for concomitant randomized clinical trials were allowed. Each Center used an early antibiotic policy (<6 hours) in case of sepsis and/or severe pneumonia diagnosis. The use of corticosteroids varied from several reasons (e.g. RCT protocol, internal policy, physician on duty with not restriction to this.
Both COVID and non-COVID patients were recruited if PaO2:FiO2 <300, bilateral community acquired pneumonia, and 2 or more of the following: increased CRP > 99mg/L, respiratory rate>25bpm or signs of respiratory distress, need for respiratory support (CPAP, MV, HFNC), creatinine>1,49mg/dl, ALT>70. Hospital-acquired and Healthcare-acquired pneumonia were excluded. Also, chronic end-stage illness (e..g. metastatic cancers, advanced neuromuscolar disorders, etc) were excluded.
The following patient caractheristics and clinical data were collected at admission: oxygenation state, vital signs, age, type of unit at admission, admission to ICU, length of hospital stay, type and duration of mechanical ventilation (MV), initial and maximal PEEP administered, ALT, WBC, platelets, Haemoglobin, presence of obesity, comorbidities, risk factors (smoking, abuse).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the consecutive patients hospitalized for severe CAP in 4 hospitals
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational study, the patients received corticosteroids according to the physician on duty | Other | – |
Primary outcome
mortality
Time frame: 2days, 7days, 30days, 60days
mortality in hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Derived from this study: PubMed 41189033Salton F, Villar J, Mondoni M, Harari S, Salotti A, Ambros A, Alba F, Ferrando C, Munoz T, Soler JA, Perez-Mendez L, Fernandez C, Martinez D, Gasparotto S, Centanni S, Zuccon U, Barbati G, Rocca A, Ruaro B, Confalonieri M, Confalonieri P. Existence and relevance of fulminant severe community-acquired pneumonia. Pneumonia (Nathan). 2025 Nov 5;17(1):26. doi: 10.1186/s41479-025-00180-0.
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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. This study is not recruiting at the moment.
MARCO CONFALONIERI, MD principal investigator
University of Trieste
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia and Severe Pneumonia, run by University of Trieste at 2 sites in Italy.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARCO CONFALONIERI, MD (+390403994667, mconfalonieri@units.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 2days, 7days, 30days, 60days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516601, which also lists 1 linked publication.
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 24 Jul 2024.