Aspiration PneumoniaAPAPINCT03763799
Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation
A study testing PCR-based microbiological diagnosis strategy and Standard microbiological diagnosis strategy in people with Aspiration Pneumonia, run by University Hospital, Lille at 2 sites in France.
Trial summary
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- PCR-based microbiological diagnosis strategy and Standard microbiological diagnosis strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Sep 2019to 22 Feb 2024
- Phase
- Interventional
- 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
Who may be able to join
- presence of risk factors for aspiration :
- known or likely swallowing dysfunction,
- altered consciousness,
- cardiac arrest,
- difficult intubation
- witnessed aspiration
Show all 12Show fewer
- symptoms and signs suggestive of lower respiratory tract pathology
- temperature ≥38.5°C or <36°C
- leukocyte count ≥10 000/µL or <1500/µL
- purulent sputum or tracheal aspirate.
- new radiographic infiltrate on chest X-ray
- tracheal intubation and mechanical ventilation since less than 48 hours
Who cannot join
- pregnant women
- refuse to participate to the study
- no informed consent
- documented bacteremia
- septic shock
- severe immunosuppression: leukocytes<1000/L or neutrophils<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4<50), and chronic corticosteroid use (>0.5 mg/kg day for at least one month during the last three months).
- moribund patients (SAPS II >90).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.
The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.
- Conditions
- Aspiration Pneumonia
- Being tested
- PCR-based microbiological diagnosis strategy, Standard microbiological diagnosis strategy
- Keywords
- Aspiration pneumonia, Invasive ventilation, PCR, Antibiotics, Tracheal aspirate
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR-based microbiological diagnosis strategyProcedure or surgery
A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
Standard microbiological diagnosis strategyProcedure or surgery
Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
| Study group | Role | What they receive |
|---|---|---|
| multiplex PCR strategy | Experimental | FilmArray® Pneumonia Panel plus Receives: Procedure: PCR-based microbiological diagnosis strategy |
| standard strategy | Active comparator | Not described Receives: Procedure: Standard microbiological diagnosis strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
Measured: 48 hours after antibiotic treatment initiation
Secondary outcomes (7)
the percentage of patients who will receive appropriate antibiotic treatment.
Measured: at Day 28 and Day 90 after antibiotic treatment initiation
the percentage of patients who will receive targeted antibiotic treatment.
Measured: at Day 28 and Day 90 after antibiotic treatment initiation
mechanical ventilation free days.
Measured: at Day 28 and Day 90 after antibiotic treatment initiation
length of ICU stay.
Measured: up to Day 90
ICU mortality.
Measured: up to Day 90
antibiotic free days.
Measured: up to Day 90
percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)
Measured: at Day 28 and Day 90 after antibiotic treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start20 Sep 2019
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saadalla NSEIR, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763799
- Sponsor's protocol ID
- 2018_40
- Other IDs
- 2018-A02219-46
- Acronym
- APAPI
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
- ClinicalTrials.gov ID
- NCT03763799
- Acronym / sponsor ID
- APAPI / 2018_40
- Conditions
- Aspiration Pneumonia
- Keywords
- Aspiration pneumonia, Invasive ventilation, PCR, Antibiotics, Tracheal aspirate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 4 Dec 2018 (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 two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.
The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiplex PCR strategy | Experimental | Procedure: PCR-based microbiological diagnosis strategyFilmArray® Pneumonia Panel plus |
| standard strategy | Active comparator | Procedure: Standard microbiological diagnosis strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- presence of risk factors for aspiration :
- known or likely swallowing dysfunction,
- altered consciousness,
- cardiac arrest,
- difficult intubation
Key exclusion criteria (7 listed)
- pregnant women
- refuse to participate to the study
- no informed consent
- documented bacteremia
- septic shock
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 |
|---|---|---|
| PCR-based microbiological diagnosis strategyA multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation | Procedure or surgery | multiplex PCR strategy |
| Standard microbiological diagnosis strategyStandard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation | Procedure or surgery | standard strategy |
Primary outcome
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
Time frame: 48 hours after antibiotic treatment initiation
7 secondary outcomes
the percentage of patients who will receive appropriate antibiotic treatment.
Time frame: at Day 28 and Day 90 after antibiotic treatment initiation
the percentage of patients who will receive targeted antibiotic treatment.
Time frame: at Day 28 and Day 90 after antibiotic treatment initiation
mechanical ventilation free days.
Time frame: at Day 28 and Day 90 after antibiotic treatment initiation
length of ICU stay.
Time frame: up to Day 90
ICU mortality.
Time frame: up to Day 90
antibiotic free days.
Time frame: up to Day 90
percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)
Time frame: at Day 28 and Day 90 after antibiotic treatment initiation
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 Dec 2025.
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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.
Saadalla NSEIR, MD,PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCR-based microbiological diagnosis strategy and Standard microbiological diagnosis strategy in people with Aspiration Pneumonia, run by University Hospital, Lille 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 12 inclusion and 7 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 Dec 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?
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment (time frame: 48 hours after antibiotic treatment initiation). 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 23 Dec 2025.