Respiratory InfectionNETMINDERSNCT04318691
Netosis in Determination of Respiratory Infection Severity
An observational study of Respiratory Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study aims to evaluate the prognostic value of alveolar and blood NETosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. The main outcome is the occurrence of an acute respiratory distress syndrome (ARDS) according to the Berlin definition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infection
- What is being tested?
- Blood sampling and Bronchoalveolar lavage
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2022to 3 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Adult ICU patients under mechanical ventilation with suspected lower-respiratory tract infection; * Adult ICU patients followed vascular surgical intervention; * Healthy Volunteers.
Who may be able to join
- A/ For all subjets:
- Be >/= 18 years of age on day of signing informed consent;
- Affiliated to the french social security - welfare system in France.
- B/ Inclusion criteria for acute respiratory failure patients:
- admitted to the ICU for acute respiratory failure requiring mechanical ventilation within the first 24 hours after admission and suspected to suffer from an infectious pneumonia, according to the following criteria:
- recent fever;
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- acute respiratory failure signs (dyspnea, polypnea > 30 cycles/min, hypoxemia PaO2<65 mmHg);
- pulmonary focal signs of auscultation;
- evocative signs in chest radiography or chest TDM.
- C/ Inclusion criteria for control patients:
- admitted to the ICU for post-operative management of vascular surgery.
Who cannot join
- A/ For all subjets:
- pregnancy,
- nosocomial pneumonia,
- no social health insurance,
- neutropenia of any cause;
- patient refusal.
- B/ Exclusion criteria for acute respiratory failure patients:
- no mechanical ventilation within the first 24 hours after admission to the ICU.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity
The study aims to evaluate the prognostic value of alveolar and blood NETosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. The main outcome is the occurrence of an acute respiratory distress syndrome (ARDS) according to the Berlin definition.
Read the detailed description
Neutrophils are the first line of defense against infectious injury. Among the numerous mechanisms involving the immune system, neutrophil extracellular traps (NETs) have been recently described as an additional way neutrophils are able to use to fight against bacteria. NETs are made of DNA and antimicrobial proteins. In the other hand, NETs promote coagulation and may contribute to evolution of severe pneumonia into acute respiratory distress syndrome.
The secondary objectives of the study include the research of the relation between blood NETosis and alveolar NETosis with:
- the documentation of invasive pulmonary infection based on microbiological analysis criteria (which would be bacteria or viral) of LBA at admission to ICU;
- the diagnosis value of usually used biomarkers: procalcitonin and C-reactive protein;
- marbrure score at admission to ICU;
- arterial lactatemia;
- scores of gravity at admission IGSII and SOFA;
- all-cause mortality at day-28;
- duration of mechanical ventilation at day-28;
- duration of amines at day-28;
- developement of hemodynamic failure;
- developement of pulmonary circulatory failure.
The study will include 1) 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure, 2) 10 control patients admitted to the ICU after a planned vascular surgery and 3) 10 healthy subjects.
- Conditions
- Respiratory Infection
- Being tested
- Blood sampling, Bronchoalveolar lavage
- Keywords
- acute respiratory distress syndrome, adult ICU, neutrophil extracellular traps (NETs), Netosis, neutrophils, mechanical ventilation, pneumonia
- Medical subject headings
- Respiratory Tract Infections, Respiratory Distress Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
Bronchoalveolar lavageProcedure or surgery
Bronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs.
| Study group | Role | What they receive |
|---|---|---|
| acute respiratory failure group | 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure Receives: Biological: Blood sampling; Procedure: Bronchoalveolar lavage | |
| vascular surgery control group | 10 control patients admitted to the ICU after a planned vascular surgery Receives: Biological: Blood sampling | |
| Healthy volunteers group | 10 healthy subjects. Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute respiratory distress syndrome occurrence
Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission
Measured: at day-7
Secondary outcomes (6)
Mortality
Vital statue of patient
Measured: At day-28
Duration of mechanical ventilation
Duration of mechanical ventilation: number of days without mechanical ventilation.
Measured: At day-28
IGSII score
IGSII score
Measured: At admission to ICU
SOFA score
SOFA score
Measured: At admission to ICU
Hemodynamic failure
Development of a hemodynamic failure
Measured: At day-28
Pulmonary circulation failure
Development of a pulmonary circulation failure (acute pulmonary heart disease, right ventricle failure)
Measured: At day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start7 Jun 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard JULLIEN, MD, Principal investigator, Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHPGuillaume Geri, MD, PhD, Study director, Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318691
- Sponsor's protocol ID
- 2020-A00217-32
- Acronym
- NETMINDERS
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity
- ClinicalTrials.gov ID
- NCT04318691
- Acronym / sponsor ID
- NETMINDERS / 2020-A00217-32
- Conditions
- Respiratory Infection
- Keywords
- acute respiratory distress syndrome, adult ICU, neutrophil extracellular traps (NETs), Netosis, neutrophils, mechanical ventilation, pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 24 Mar 2020 (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.
The study aims to evaluate the prognostic value of alveolar and blood NETosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. The main outcome is the occurrence of an acute respiratory distress syndrome (ARDS) according to the Berlin definition.
Detailed description
Neutrophils are the first line of defense against infectious injury. Among the numerous mechanisms involving the immune system, neutrophil extracellular traps (NETs) have been recently described as an additional way neutrophils are able to use to fight against bacteria. NETs are made of DNA and antimicrobial proteins. In the other hand, NETs promote coagulation and may contribute to evolution of severe pneumonia into acute respiratory distress syndrome.
The secondary objectives of the study include the research of the relation between blood NETosis and alveolar NETosis with:
- the documentation of invasive pulmonary infection based on microbiological analysis criteria (which would be bacteria or viral) of LBA at admission to ICU;
- the diagnosis value of usually used biomarkers: procalcitonin and C-reactive protein;
- marbrure score at admission to ICU;
- arterial lactatemia;
- scores of gravity at admission IGSII and SOFA;
- all-cause mortality at day-28;
- duration of mechanical ventilation at day-28;
- duration of amines at day-28;
- developement of hemodynamic failure;
- developement of pulmonary circulatory failure.
The study will include 1) 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure, 2) 10 control patients admitted to the ICU after a planned vascular surgery and 3) 10 healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute respiratory failure group | – | Biological: Blood sampling, Procedure: Bronchoalveolar lavage60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure |
| vascular surgery control group | – | Biological: Blood sampling10 control patients admitted to the ICU after a planned vascular surgery |
| Healthy volunteers group | – | Biological: Blood sampling10 healthy subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Adult ICU patients under mechanical ventilation with suspected lower-respiratory tract infection; * Adult ICU patients followed vascular surgical intervention; * Healthy Volunteers.
Key inclusion criteria (11 listed)
- Be >/= 18 years of age on day of signing informed consent;
- Affiliated to the french social security - welfare system in France.
- admitted to the ICU for acute respiratory failure requiring mechanical ventilation within the first 24 hours after admission and suspected to suffer from an infectious pneumonia, according to the following criteria:
- recent fever;
- acute respiratory failure signs (dyspnea, polypnea > 30 cycles/min, hypoxemia PaO2<65 mmHg);
Key exclusion criteria (8 listed)
- pregnancy,
- nosocomial pneumonia,
- no social health insurance,
- neutropenia of any cause;
- patient refusal.
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 |
|---|---|---|
| Blood samplingBlood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs. | Biological | Healthy volunteers group, acute respiratory failure group, vascular surgery control group |
| Bronchoalveolar lavageBronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs. | Procedure or surgery | acute respiratory failure group |
Primary outcome
Acute respiratory distress syndrome occurrence
Time frame: at day-7
Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission
6 secondary outcomes
Mortality
Time frame: At day-28
Duration of mechanical ventilation
Time frame: At day-28
IGSII score
Time frame: At admission to ICU
SOFA score
Time frame: At admission to ICU
Hemodynamic failure
Time frame: At day-28
Pulmonary circulation failure
Time frame: At day-28
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 16 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Edouard JULLIEN, MD principal investigator
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Guillaume Geri, MD, PhD study director
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
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 Respiratory Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 inclusion and 8 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 16 Mar 2023. 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 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?
Acute respiratory distress syndrome occurrence (time frame: at day-7). 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 16 Mar 2023.