PneumoniaRESPIRENCT07425561
Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)
An observational study of Pneumonia and Pneumonia - Bacterial, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pneumonia, Pneumonia - Bacterial, Multi Drug Resistant
- What is being tested?
- RESPIRE score
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 8 Feb 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the initial retrospective observational phase (2 years), data were collected to establish a retrospective derivation cohort composed of patients with microbiologically confirmed etiological diagnoses of pneumonia. The derivation cohort includes patients who underwent microbiological investigations aimed at identifying the etiological cause of pneumonia within the first 48 hours of presentation to Azienda Ospedaliero Universitaria Careggi. During the second prospective observational phase (2 years), data were collected to establish a prospective cohort of Emergency Department patients, in which the performance of the clinical score derived from the retrospective cohort was evaluated in a purely observational manner.
Who may be able to join
- All patients:
- aged ≥18 years
- who underwent respiratory sample collection within 48 hours of hospital admission and had subsequent positive culture results oleading to a confirmed etiological diagnosis of community-acquired pneumonia (CAP)
- Pneumonia was clinically defined by the presence of two or more clinical signs or symptoms (body temperature <36.0°C or >38.0°C; respiratory rate >20 breaths/min; oxygen saturation on room air <90%; arterial partial pressure of oxygen <60 mmHg; cough; sputum production; white blood cell count <4,000/μL or >10,000/μL; bandemia >10%), in addition to radiographic evidence of a new parenchymal opacity or cavitation.
- Only patients with positive respiratory culture results were included in the analysis.
- During the prospective phase, only patients whose microbiological samples were collected in the Emergency Department were enrolled.
Who cannot join
- informed consent was not provided
- age was <18 years or >90 years
- pregnant
- pneumonia occurred after more than 48 hours from hospital admission (hospital-acquired pneumonia).
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods.
The primary objective of the study is to derive a clinical predictive score for multidrug-resistant (MDR) pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
Read the detailed description
Study Design and Setting
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase and a subsequent prospective phase. Patients were enrolled during two consecutive, non-overlapping periods: from January 1, 2022 to December 31, 2023 (retrospective cohort), and from January 1, 2024 to December 31, 2025 (prospective cohort).
The study was conducted in a hospital setting and is monocentric, carried out at the Emergency Department and the Emergency Sub-Intensive Care Unit of Azienda Ospedaliero Universitaria Careggi, in collaboration with the Units of Microbiology and Virology and Infectious Diseases. Careggi is a large academic hospital that serves as the local hospital for a population of approximately 650,000 inhabitants and acts as a tertiary referral center for about 1,600,000 people.
Retrospective Phase (Derivation Cohort)
During the first observational retrospective phase (2 years), data were collected to establish a retrospective derivation cohort composed of patients with microbiologically confirmed etiological diagnoses of pneumonia. The derivation cohort includes patients who underwent microbiological investigations aimed at identifying the etiological diagnosis of pneumonia within the first 48 hours from admission to Azienda Ospedaliero Universitaria Careggi.
Following an initial screening of microbiological test requests received by the Microbiology and Virology Laboratory-using dedicated software containing microbiological investigations and electronic medical records of patients with pneumonia-patients who underwent diagnostic testing to determine the etiological agent of pneumonia (bacterial, viral, or fungal) on respiratory samples (considered the diagnostic gold standard for etiological assessment) within 48 hours of hospital admission were identified. Subsequently, patients' medical records were reviewed by the investigators to construct the final cohort database.
During the retrospective phase, patients with microbiologically confirmed bacterial, fungal, or viral pneumonia were included in order to create the retrospective cohort. Cases in which no bacterial, fungal, or viral pathogen was identified were excluded. Only patients with positive culture results and available antimicrobial susceptibility testing were selected. Patients with bacterial pneumonia caused by multidrug-resistant (MDR) pathogens identified on culture constituted the study group, whereas patients with bacterial pneumonia caused by non-MDR pathogens constituted the control group. MDR pneumonia was defined as pneumonia caused by bacterial pathogens exhibiting acquired non-susceptibility to at least one agent in three or more antimicrobial categories.
Only patients with a confirmed etiological diagnosis of pneumonia and positive culture results were included, in order to avoid the inclusion of false-negative cases. Negative respiratory culture results (reported in the literature in approximately 40-60% of cases) could have introduced potential selection bias, as culture-negative results do not allow exclusion of pneumonia caused by MDR pathogens.
Prospective Phase (Validation Cohort)
During the second observational prospective phase (2 years), data were collected to establish a prospective cohort of Emergency Department patients, on which the performance of the clinical score derived from the retrospective cohort was evaluated in a purely observational manner.
The validation cohort includes patients diagnosed with pneumonia who underwent microbiological investigations on respiratory samples in the Emergency Department to assess the etiological agent. No additional diagnostic tests were performed beyond routine clinical practice. Only patients with pneumonia who underwent microbiological investigations on respiratory samples at the clinician's discretion were included. After an initial phase, only patients with positive respiratory culture results were included, for the same reasons described above.
The Units of Emergency Medicine and Surgery and Integrated Clinical Assessment and In-Hospital Emergency Pathways were responsible for patient assessment, enrollment, sample collection, and data collection. The Unit of Microbiology and Virology was responsible for identifying microbiological test requests received by the laboratory during the study period and for extracting microbiological data.
Study Objectives
The primary objective of the study is to derive a clinical predictive score for MDR pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
Secondary objectives are:
- validation of the derived clinical score in a prospective patient cohort;
- comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores such as DRIP, Shorr, Park, Shindo, Aliberti, and Schreiber, as well as the ATS/IDSA HCAP criteria;
- analysis of positive predictive value (PPV), negative predictive value (NPV), specificity, sensitivity, positive and negative likelihood ratios (LR+ and LR-), and optimal cut-off values;
- assessment of score calibration in both the derivation and validation cohorts;
- evaluation of clinical impact using decision curve analysis.
- Conditions
- Pneumonia, Pneumonia - Bacterial, Multi Drug Resistant, Multi Drug Resistant Organisms, Emergency, Community Acquired Pneumonia
- Being tested
- RESPIRE score
- Keywords
- Pneumonia, Bacterial, Multi Drug Resistant, Emergency Department, CAP, Community acquired pneumonia
- Medical subject headings
- Pneumonia, Pneumonia, Bacterial, Emergencies, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPIRE scoreOther
RESPIRE is a clinical risk prediction score developed to estimate the probability of pneumonia caused by multidrug-resistant (MDR) pathogens. In this observational study, the RESPIR-E score is derived and validated using routinely collected clinical and microbiological data. The score is not applied to guide clinical decision-making and does not influence diagnostic or therapeutic management. It is evaluated solely for observational and research purposes.
| Study group | Role | What they receive |
|---|---|---|
| MDR Pneumonia Group (Derivation Cohort) | Patients with microbiologically confirmed bacterial pneumonia caused by multidrug-resistant (MDR) pathogens, identified on respiratory culture and antimicrobial susceptibility testing, enrolled during the retrospective phase. MDR was defined as acquired non-susceptibility to at least one agent in three or more antimicrobial categories. Receives: Other: RESPIRE score | |
| Non-MDR Pneumonia Group (Derivation Cohort) | Patients with microbiologically confirmed bacterial pneumonia caused by non-multidrug-resistant pathogens, identified on respiratory culture with available antimicrobial susceptibility testing, enrolled during the retrospective phase. This group served as the comparison cohort for score derivation. Receives: Other: RESPIRE score | |
| Pneumonia Validation Cohort (Prospective) | Consecutive patients presenting to the Emergency Department with a diagnosis of pneumonia who underwent microbiological investigations on respiratory samples during the prospective phase (January 1, 2024-December 31, 2025). This cohort was used to prospectively validate the clinical predictive score derived from the retrospective cohort in a purely observational manner. Receives: Other: RESPIRE score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical score (RESPIRE) derivation
The primary objective of the study is to derive a clinical predictive score for MDR pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
Measured: Within 48 hours from Emergency Department presentation / hospital admission.
Secondary outcomes (5)
validation of the derived clinical score in a prospective patient cohort;
validation of the derived clinical score in a prospective patient cohort;
Measured: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores
comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores such as DRIP, Shorr, Park, Shindo, Aliberti, and Schreiber, as well as the ATS/IDSA HCAP criteria (Measure: Area under the curve,sensibility, specificity, PPV, NPV, +LR, -LR)
Measured: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
PPV, NPV, specificity, sensitivity, LR+, LR-, Youden
analysis of positive predictive value (PPV), negative predictive value (NPV), specificity, sensitivity, positive and negative likelihood ratios (LR+ and LR-), and optimal cut-off values;
Measured: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
Calibration
assessment of score calibration in both the derivation and validation cohorts;
Measured: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
Clinical utiliy
evaluation of clinical impact using decision curve analysis (eg. treatment variation %)
Measured: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jan 2022
- Primary completion1 Feb 2026
- Study completion8 Feb 2026
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 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
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425561
- Sponsor's protocol ID
- CEAVC 29707
- Acronym
- RESPIRE
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are not publicly available due to their containing information that could compromise the privacy of research participants
Publications
Pelagatti L, De Marco M, Bosco E, Catalucci T, Gilardoni M, Mangani F, Spinicci M, Bartoloni A, Rossolini GM, Nazerian P, Vanni S. RESPIRE Score: Derivation and Validation of a New Risk Score for Prediction of Community-acquired Pneumonia Caused by Resistant Pathogens. Open Forum Infect Dis. 2026 May 21;13(6):ofag319. doi: 10.1093/ofid/ofag319. eCollection 2026 Jun.
PubMed 42238377
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)
- ClinicalTrials.gov ID
- NCT07425561
- Acronym / sponsor ID
- RESPIRE / CEAVC 29707
- Conditions
- Pneumonia, Pneumonia - Bacterial, Multi Drug Resistant, Multi Drug Resistant Organisms, Emergency, Community Acquired Pneumonia
- Keywords
- Pneumonia, Bacterial, Multi Drug Resistant, Emergency Department, CAP, Community acquired pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 8 Feb 2026 (actual)
- First posted
- 23 Feb 2026 (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.
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods.
The primary objective of the study is to derive a clinical predictive score for multidrug-resistant (MDR) pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
Detailed description
Study Design and Setting
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase and a subsequent prospective phase. Patients were enrolled during two consecutive, non-overlapping periods: from January 1, 2022 to December 31, 2023 (retrospective cohort), and from January 1, 2024 to December 31, 2025 (prospective cohort).
The study was conducted in a hospital setting and is monocentric, carried out at the Emergency Department and the Emergency Sub-Intensive Care Unit of Azienda Ospedaliero Universitaria Careggi, in collaboration with the Units of Microbiology and Virology and Infectious Diseases. Careggi is a large academic hospital that serves as the local hospital for a population of approximately 650,000 inhabitants and acts as a tertiary referral center for about 1,600,000 people.
Retrospective Phase (Derivation Cohort)
During the first observational retrospective phase (2 years), data were collected to establish a retrospective derivation cohort composed of patients with microbiologically confirmed etiological diagnoses of pneumonia. The derivation cohort includes patients who underwent microbiological investigations aimed at identifying the etiological diagnosis of pneumonia within the first 48 hours from admission to Azienda Ospedaliero Universitaria Careggi.
Following an initial screening of microbiological test requests received by the Microbiology and Virology Laboratory-using dedicated software containing microbiological investigations and electronic medical records of patients with pneumonia-patients who underwent diagnostic testing to determine the etiological agent of pneumonia (bacterial, viral, or fungal) on respiratory samples (considered the diagnostic gold standard for etiological assessment) within 48 hours of hospital admission were identified. Subsequently, patients' medical records were reviewed by the investigators to construct the final cohort database.
During the retrospective phase, patients with microbiologically confirmed bacterial, fungal, or viral pneumonia were included in order to create the retrospective cohort. Cases in which no bacterial, fungal, or viral pathogen was identified were excluded. Only patients with positive culture results and available antimicrobial susceptibility testing were selected. Patients with bacterial pneumonia caused by multidrug-resistant (MDR) pathogens identified on culture constituted the study group, whereas patients with bacterial pneumonia caused by non-MDR pathogens constituted the control group. MDR pneumonia was defined as pneumonia caused by bacterial pathogens exhibiting acquired non-susceptibility to at least one agent in three or more antimicrobial categories.
Only patients with a confirmed etiological diagnosis of pneumonia and positive culture results were included, in order to avoid the inclusion of false-negative cases. Negative respiratory culture results (reported in the literature in approximately 40-60% of cases) could have introduced potential selection bias, as culture-negative results do not allow exclusion of pneumonia caused by MDR pathogens.
Prospective Phase (Validation Cohort)
During the second observational prospective phase (2 years), data were collected to establish a prospective cohort of Emergency Department patients, on which the performance of the clinical score derived from the retrospective cohort was evaluated in a purely observational manner.
The validation cohort includes patients diagnosed with pneumonia who underwent microbiological investigations on respiratory samples in the Emergency Department to assess the etiological agent. No additional diagnostic tests were performed beyond routine clinical practice. Only patients with pneumonia who underwent microbiological investigations on respiratory samples at the clinician's discretion were included. After an initial phase, only patients with positive respiratory culture results were included, for the same reasons described above.
The Units of Emergency Medicine and Surgery and Integrated Clinical Assessment and In-Hospital Emergency Pathways were responsible for patient assessment, enrollment, sample collection, and data collection. The Unit of Microbiology and Virology was responsible for identifying microbiological test requests received by the laboratory during the study period and for extracting microbiological data.
Study Objectives
The primary objective of the study is to derive a clinical predictive score for MDR pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
Secondary objectives are:
- validation of the derived clinical score in a prospective patient cohort;
- comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores such as DRIP, Shorr, Park, Shindo, Aliberti, and Schreiber, as well as the ATS/IDSA HCAP criteria;
- analysis of positive predictive value (PPV), negative predictive value (NPV), specificity, sensitivity, positive and negative likelihood ratios (LR+ and LR-), and optimal cut-off values;
- assessment of score calibration in both the derivation and validation cohorts;
- evaluation of clinical impact using decision curve analysis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDR Pneumonia Group (Derivation Cohort) | – | Other: RESPIRE scorePatients with microbiologically confirmed bacterial pneumonia caused by multidrug-resistant (MDR) pathogens, identified on respiratory culture and antimicrobial susceptibility testing, enrolled during the retrospective phase. MDR was defined as acquired non-susceptibility to at least one agent in three or more antimicrobial categories. |
| Non-MDR Pneumonia Group (Derivation Cohort) | – | Other: RESPIRE scorePatients with microbiologically confirmed bacterial pneumonia caused by non-multidrug-resistant pathogens, identified on respiratory culture with available antimicrobial susceptibility testing, enrolled during the retrospective phase. This group served as the comparison cohort for score derivation. |
| Pneumonia Validation Cohort (Prospective) | – | Other: RESPIRE scoreConsecutive patients presenting to the Emergency Department with a diagnosis of pneumonia who underwent microbiological investigations on respiratory samples during the prospective phase (January 1, 2024-December 31, 2025). This cohort was used to prospectively validate the clinical predictive score derived from the retrospective cohort in a purely observational manner. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the initial retrospective observational phase (2 years), data were collected to establish a retrospective derivation cohort composed of patients with microbiologically confirmed etiological diagnoses of pneumonia. The derivation cohort includes patients who underwent microbiological investigations aimed at identifying the etiological cause of pneumonia within the first 48 hours of presentation to Azienda Ospedaliero Universitaria Careggi. During the second prospective observational phase (2 years), data were collected to establish a prospective cohort of Emergency Department patients, in which the performance of the clinical score derived from the retrospective cohort was evaluated in a purely observational manner.
Key inclusion criteria (6 listed)
- aged ≥18 years
- who underwent respiratory sample collection within 48 hours of hospital admission and had subsequent positive culture results oleading to a confirmed etiological diagnosis of community-acquired pneumonia (CAP)
- Pneumonia was clinically defined by the presence of two or more clinical signs or symptoms (body temperature <36.0°C or >38.0°C; respiratory rate >20 breaths/min; oxygen saturation on room air <90%; arterial partial pressure of oxygen <60 mmHg; cough; sputum production; white blood cell count <4,000/μL or >10,000/μL; bandemia >10%), in addition to radiographic evidence of a new parenchymal opacity or cavitation.
- Only patients with positive respiratory culture results were included in the analysis.
- During the prospective phase, only patients whose microbiological samples were collected in the Emergency Department were enrolled.
Key exclusion criteria (4 listed)
- informed consent was not provided
- age was <18 years or >90 years
- pregnant
- pneumonia occurred after more than 48 hours from hospital admission (hospital-acquired pneumonia).
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 |
|---|---|---|
| RESPIRE scoreRESPIRE is a clinical risk prediction score developed to estimate the probability of pneumonia caused by multidrug-resistant (MDR) pathogens. In this observational study, the RESPIR-E score is derived and validated using routinely collected clinical and microbiological data. The score is not applied to guide clinical decision-making and does not influence diagnostic or therapeutic management. It is evaluated solely for observational and research purposes. | Other | MDR Pneumonia Group (Derivation Cohort), Non-MDR Pneumonia Group (Derivation Cohort), Pneumonia Validation Cohort (Prospective) |
Primary outcome
Clinical score (RESPIRE) derivation
Time frame: Within 48 hours from Emergency Department presentation / hospital admission.
The primary objective of the study is to derive a clinical predictive score for MDR pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
5 secondary outcomes
validation of the derived clinical score in a prospective patient cohort;
Time frame: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores
Time frame: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
PPV, NPV, specificity, sensitivity, LR+, LR-, Youden
Time frame: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
Calibration
Time frame: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
Clinical utiliy
Time frame: Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 42238377Pelagatti L, De Marco M, Bosco E, Catalucci T, Gilardoni M, Mangani F, Spinicci M, Bartoloni A, Rossolini GM, Nazerian P, Vanni S. RESPIRE Score: Derivation and Validation of a New Risk Score for Prediction of Community-acquired Pneumonia Caused by Resistant Pathogens. Open Forum Infect Dis. 2026 May 21;13(6):ofag319. doi: 10.1093/ofid/ofag319. eCollection 2026 Jun.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not publicly available due to their containing information that could compromise the privacy of research participants
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Pneumonia - Bacterial, run by Azienda Ospedaliero-Universitaria Careggi at 1 site 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical score (RESPIRE) derivation (time frame: Within 48 hours from Emergency Department presentation / hospital admission.). 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 NCT07425561, 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 23 Feb 2026.