Infectious PneumoniaKIDNAPNCT03182387
Key to Improve DiagNosis in Aspiration Pneumonia
An observational study of Infectious Pneumonia and Coma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Pneumonia, Coma
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2017to 19 Nov 2020
- 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: Patient admitted to ICU with mechanical ventilation need.
Who may be able to join
- Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).
- Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °> 38 ° C).
- Age ≥18 years
- Patient affiliated to the social security system.
- No opposition obtained
Who cannot join
- Immunocompromised patient.
- Cardiorespiratory arrest requiring therapeutic hypothermia.
- Pneumopathy nosocomiale (pneumopathy beginning> 48h after hospital admission).
- Infectious Pneumonia in the previous 30 days.
- Previous hospitalization in the previous 30 days.
- Patient under antibiotic at baseline.
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- Bacteremia.
- Mechanical ventilation begun before unconsciousness.
- Report Pa02 / FI02 <80.
- Patient under curatorship and / or guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.
To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.
Read the detailed description
Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.
- Conditions
- Infectious Pneumonia, Coma
- Keywords
- Bronchoalveolar lavage, amylase assay, aspiration pneumonia
- Medical subject headings
- Coma, Pneumonia, Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificityof amylase test.
Amylase culture in bronchoalveolar fluid is compared to gold standard culture
Measured: 5 days after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start21 Aug 2017
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Wittkop, PhD, Study chair, USMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182387
- Sponsor's protocol ID
- CHUBX 2015/38
- Acronym
- KIDNAP
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2017
- Last updated
- 7 Jun 2021
- 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 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.
- ClinicalTrials.gov ID
- NCT03182387
- Acronym / sponsor ID
- KIDNAP / CHUBX 2015/38
- Conditions
- Infectious Pneumonia, Coma
- Keywords
- Bronchoalveolar lavage, amylase assay, aspiration pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 9 Jun 2017 (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.
To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.
Detailed description
Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to ICU with mechanical ventilation need.
Key inclusion criteria (5 listed)
- Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).
- Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °> 38 ° C).
- Age ≥18 years
- Patient affiliated to the social security system.
- No opposition obtained
Key exclusion criteria (10 listed)
- Immunocompromised patient.
- Cardiorespiratory arrest requiring therapeutic hypothermia.
- Pneumopathy nosocomiale (pneumopathy beginning> 48h after hospital admission).
- Infectious Pneumonia in the previous 30 days.
- Previous hospitalization in the previous 30 days.
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
Sensitivity and specificityof amylase test.
Time frame: 5 days after inclusion day
Amylase culture in bronchoalveolar fluid is compared to gold standard culture
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 Jun 2021.
- 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.
Linda Wittkop, PhD study chair
USMR
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 Infectious Pneumonia and Coma, run by University Hospital, Bordeaux 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 5 inclusion and 10 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 Jun 2021. 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?
Sensitivity and specificityof amylase test. (time frame: 5 days after inclusion day). 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 Jun 2021.