Acute Respiratory Distress Syndrome (ARDS)FROG-ARDSNCT06779942
The Association Between IL17, Acute Respiratory Distress Syndrome and Acute Respiratory Failure
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF), run by Bayer at 2 sites in France.
Trial summary
This study will look at a protein called Interleukin (IL)-17A and how it relates to health markers in patients with a serious lung condition known as Acute Respiratory Distress Syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)
- How many people
- 414 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Dec 2024to 31 Dec 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: Using the data from FROG ICU registry, we will create two cohorts of patients using diagnosis codes: Acute Respiratory Distress Syndrome (ARDS) Acute Respiratory Failure (ARF) The FROG ICU registry is a completed, prospective, observational, multicenter cohort study, designed to assess the incidence and to identify the risk factors of all-cause mortality during the year following discharge from the ICU. Our study will retrospectively analyze this prospectively collected data. The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes.
Who may be able to join
- invasive mechanical ventilation support for at least 24 h and/or treatment with a positive inotropic agent (except dopamine) for more than 24 h
- ARDS patients:
- o Diagnosis of ARDS at the time of study inclusion and within 24-48 hours of bio sample collection
- ARF patients o Diagnosis of Acute respiratory Failure (ARF) who do not have sepsis at the time of study inclusion and within 24-48 hours of bio sample collection
Who cannot join
- o Patients with ARF who later develop ARDS after the 24-48 hour bio sample draw time period will be excluded as they will not have had baseline bio samples drawn in relation to onset of ARDS.
- Patients less than 18 years old
- severe head injury (initial Glasgow Coma Scale < 8) or brain death or a persistent vegetative state
- pregnancy or breastfeeding
- transplantation in the past 12 months; not expected to survive or to leave the hospital
- no social security coverage
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: FROG-ARDS: Correlation of IL-17A to Hyperinflammatory Biomarkers, Sub-phenotype, and Clinical Outcomes in Patients With Acute Respiratory Distress Syndrome in the FROG ICU Dataset
This study will look at a protein called Interleukin (IL)-17A and how it relates to health markers in patients with a serious lung condition known as Acute Respiratory Distress Syndrome (ARDS). IL-17A is part of the immune system and helps the body fight infections, but too much of it can lead to inflammation, which can be harmful.
The researchers want to find out if the levels of IL-17A in the blood are connected to important health outcomes for patients, such as whether they survive in the Intensive Care Unit (ICU), after 30 days, and after 60 days. They will also check how long patients can stay off a ventilator and how many days they need to use a mechanical ventilator. A ventilator is a machine that helps people breathe when their lungs are not working well.
Read more
In addition to the main goal, the researchers will study how IL-17A relates to a severe form of ARDS called the hyperinflammatory sub-phenotype. They will also look at how IL-17A connects with other health markers, including IL-6, soluble tumor necrosis factor receptor (sTNFR), IL8, Tumor Necrosis Factor (TNF)a, IL1beta, and IL23. These markers can give information about inflammation and how the body is responding to illness.
To compare results, the researchers will include a control group of patients who had Acute Respiratory Failure (ARF) but did not have ARDS. This control group will help them understand the differences between the two conditions.
This research will use data from the FROG-ICU Registry, which gathers information on patients in intensive care units across Europe. The registry tracks patients' health after they leave the ICU, focusing on the risk factors for death in the year following their discharge. The data comes from 28 different ICUs in 19 hospitals.
The researchers will create two groups of patients based on their diagnoses: one group with ARDS and another with ARF. By studying these groups, they hope to learn more about the role of IL-17A in ARDS and its potential impact on patient outcomes.
- Keywords
- Acute respiratory distress syndrome (ARDS), Acute Respiratory Failure (ARF), IL-17 Inhibitor
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Respiratory Distress Syndrome (ARDS) | The index date is the date of diagnosis of ARDS. The patients will be followed from the index date until the outcome, death, or end of follow-up whichever comes first. This study builds on data from FROG ICU registry, which is an observational, prospective, multicenter cohort study. The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes. Patient Identification period: Aug 2011 - Jun 2013 Exposure window: ICU admission to discharge | |
| Acute Respiratory Failure (ARF) | The index date is the date of diagnosis of ARF. The patients will be followed from the index date until the outcome, death, or end of follow-up whichever comes first. This study builds on data from FROG ICU registry, which is an observational, prospective, multicenter cohort study. The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes. Patient Identification period: Aug 2011 - Jun 2013 Exposure window: ICU admission to discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Evaluate the association between Interleukin (IL)-17A level and mortality at the Intensive Care Unit (ICU) in patients with ARDS
Measured: Baseline to ICU discharge (at least 24h) or death
30 Day Mortality
Evaluate the association between IL-17A level and 30 Day mortality in patients with ARDS
Measured: Baseline to 30 days after ICU admission or death
60 Day Mortality
Evaluate the association between IL-17A level and 60 Day mortality in patients with ARDS
Measured: Baseline to 60 days after ICU admission or death
Ventilator free survival
Evaluate the association between IL-17A level and ventilator free survival in patients with ARDS
Measured: From baseline to ICU discharge, but at least for 24 hrs
Number of days on mechanical ventilator
Evaluate the association between IL-17A level and days on mechanical ventilator in patients with ARDS
Measured: From baseline to ICU discharge, but at least for 24 hrs
Secondary outcomes (4)
Hyperinflammatory ARDS subtype correlation
Evaluate the association between IL-17A and hyperinflammatory sub-phenotype of ARDS
Measured: From baseline to ICU discharge, but at least for 24 hrs
Biomarker Correlation with IL-17A
Evaluate the correlation between IL-17A and multiple biomarkers including IL-6, sTNFR, IL8, Tumour Necrosis Factor (TNF)a, IL1beta, IL23 in patients with ARDS
Measured: From baseline to ICU discharge, but at least for 24 hrs
Comparison of associated biomarkers in hypo-inflammatory phenotype of ARDS
Compare these associations with the association with these biomarkers in hypo-inflammatory phenotype of ARDS
Measured: From baseline to ICU discharge, but at least for 24 hrs
Comparison of associated biomarkers in hyper and hypo-inflammatory phenotypes of Acute Respiratory Failure (ARF)
Compare these associations with the association with these biomarkers in the hyper and hypo-inflammatory phenotypes of Acute Respiratory Failure (ARF)
Measured: From baseline to ICU discharge, but at least for 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Dec 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779942
- Sponsor's protocol ID
- 22920
- Acronym
- FROG-ARDS
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FROG-ARDS: Correlation of IL-17A to Hyperinflammatory Biomarkers, Sub-phenotype, and Clinical Outcomes in Patients With Acute Respiratory Distress Syndrome in the FROG ICU Dataset
- ClinicalTrials.gov ID
- NCT06779942
- Acronym / sponsor ID
- FROG-ARDS / 22920
- Keywords
- Acute respiratory distress syndrome (ARDS), Acute Respiratory Failure (ARF), IL-17 Inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Jan 2025 (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 study will look at a protein called Interleukin (IL)-17A and how it relates to health markers in patients with a serious lung condition known as Acute Respiratory Distress Syndrome (ARDS). IL-17A is part of the immune system and helps the body fight infections, but too much of it can lead to inflammation, which can be harmful.
The researchers want to find out if the levels of IL-17A in the blood are connected to important health outcomes for patients, such as whether they survive in the Intensive Care Unit (ICU), after 30 days, and after 60 days. They will also check how long patients can stay off a ventilator and how many days they need to use a mechanical ventilator. A ventilator is a machine that helps people breathe when their lungs are not working well.
In addition to the main goal, the researchers will study how IL-17A relates to a severe form of ARDS called the hyperinflammatory sub-phenotype. They will also look at how IL-17A connects with other health markers, including IL-6, soluble tumor necrosis factor receptor (sTNFR), IL8, Tumor Necrosis Factor (TNF)a, IL1beta, and IL23. These markers can give information about inflammation and how the body is responding to illness.
To compare results, the researchers will include a control group of patients who had Acute Respiratory Failure (ARF) but did not have ARDS. This control group will help them understand the differences between the two conditions.
This research will use data from the FROG-ICU Registry, which gathers information on patients in intensive care units across Europe. The registry tracks patients' health after they leave the ICU, focusing on the risk factors for death in the year following their discharge. The data comes from 28 different ICUs in 19 hospitals.
The researchers will create two groups of patients based on their diagnoses: one group with ARDS and another with ARF. By studying these groups, they hope to learn more about the role of IL-17A in ARDS and its potential impact on patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Distress Syndrome (ARDS) | – | –The index date is the date of diagnosis of ARDS. The patients will be followed from the index date until the outcome, death, or end of follow-up whichever comes first. This study builds on data from FROG ICU registry, which is an observational, prospective, multicenter cohort study. The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes. Patient Identification period: Aug 2011 - Jun 2013 Exposure window: ICU admission to discharge |
| Acute Respiratory Failure (ARF) | – | –The index date is the date of diagnosis of ARF. The patients will be followed from the index date until the outcome, death, or end of follow-up whichever comes first. This study builds on data from FROG ICU registry, which is an observational, prospective, multicenter cohort study. The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes. Patient Identification period: Aug 2011 - Jun 2013 Exposure window: ICU admission to discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Using the data from FROG ICU registry, we will create two cohorts of patients using diagnosis codes: Acute Respiratory Distress Syndrome (ARDS) Acute Respiratory Failure (ARF) The FROG ICU registry is a completed, prospective, observational, multicenter cohort study, designed to assess the incidence and to identify the risk factors of all-cause mortality during the year following discharge from the ICU. Our study will retrospectively analyze this prospectively collected data. The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes.
Key inclusion criteria (4 listed)
- invasive mechanical ventilation support for at least 24 h and/or treatment with a positive inotropic agent (except dopamine) for more than 24 h
- ARDS patients:
- o Diagnosis of ARDS at the time of study inclusion and within 24-48 hours of bio sample collection
- ARF patients o Diagnosis of Acute respiratory Failure (ARF) who do not have sepsis at the time of study inclusion and within 24-48 hours of bio sample collection
Key exclusion criteria (6 listed)
- o Patients with ARF who later develop ARDS after the 24-48 hour bio sample draw time period will be excluded as they will not have had baseline bio samples drawn in relation to onset of ARDS.
- Patients less than 18 years old
- severe head injury (initial Glasgow Coma Scale < 8) or brain death or a persistent vegetative state
- pregnancy or breastfeeding
- transplantation in the past 12 months; not expected to survive or to leave the hospital
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
ICU Mortality
Time frame: Baseline to ICU discharge (at least 24h) or death
Evaluate the association between Interleukin (IL)-17A level and mortality at the Intensive Care Unit (ICU) in patients with ARDS
30 Day Mortality
Time frame: Baseline to 30 days after ICU admission or death
Evaluate the association between IL-17A level and 30 Day mortality in patients with ARDS
60 Day Mortality
Time frame: Baseline to 60 days after ICU admission or death
Evaluate the association between IL-17A level and 60 Day mortality in patients with ARDS
Ventilator free survival
Time frame: From baseline to ICU discharge, but at least for 24 hrs
Evaluate the association between IL-17A level and ventilator free survival in patients with ARDS
Number of days on mechanical ventilator
Time frame: From baseline to ICU discharge, but at least for 24 hrs
Evaluate the association between IL-17A level and days on mechanical ventilator in patients with ARDS
4 secondary outcomes
Hyperinflammatory ARDS subtype correlation
Time frame: From baseline to ICU discharge, but at least for 24 hrs
Biomarker Correlation with IL-17A
Time frame: From baseline to ICU discharge, but at least for 24 hrs
Comparison of associated biomarkers in hypo-inflammatory phenotype of ARDS
Time frame: From baseline to ICU discharge, but at least for 24 hrs
Comparison of associated biomarkers in hyper and hypo-inflammatory phenotypes of Acute Respiratory Failure (ARF)
Time frame: From baseline to ICU discharge, but at least for 24 hrs
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 7 Feb 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
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 Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF), run by Bayer at 2 sites in France.
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 4 inclusion and 6 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 7 Feb 2025. 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 France. 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?
ICU Mortality (time frame: Baseline to ICU discharge (at least 24h) or death). The study lists 5 primary outcomes in all. 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 7 Feb 2025.