Ventilator Associated PneumoniaASPICNCT05671328
Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia
An observational study of Ventilator Associated Pneumonia and Pulmonary Aspergillosis Invasive, run by University Hospital, Lille at 1 site in France.
Trial summary
Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Pulmonary Aspergillosis Invasive
- What is being tested?
- Biological examinations performed on blood and BAL
- How many people
- 263 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2023to 18 Jul 2025
- 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: Patients hospitalized in ICU
Who may be able to join
- Adult patient (age ≥ 18 years),
- On invasive ventilation for more than 48 hours,
- Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria:
- Fever ≥ 38° C or hypothermia ≤ 36.5° C
- Leukocytes > 12x109 or < 4x109/L
- Purulent tracheal secretions
Who cannot join
- Neutropenic patients (neutrophils < 0.5G/L),
- Previous diagnosis of IPA,
- Minor patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Incidence of Invasive Pulmonary Aspergillosis in Patients With Suspected Ventilator-associated Pneumonia
Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.
- Being tested
- Biological examinations performed on blood and BAL
- Keywords
- Pulmonary invasive aspergillosis, ventilator-associated-pneumonia, mechanical ventilation, nosocomial infections
- Medical subject headings
- Pneumonia, Ventilator-Associated, Invasive Pulmonary Aspergillosis, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological examinations performed on blood and BALOther
Direct examination and culture of BAL Galactomannan in serum and BAL Serum 1,3 beta D glucans Aspergillus PCR in BAL
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected ventilator-associated pneumonia | Not described Receives: Other: Biological examinations performed on blood and BAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
Measured: On the 1 day of inclusion
Secondary outcomes (6)
Incidence of IPA according to the Blot criteria
Measured: On the 1 day of inclusion
Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria
Measured: On the 1 day of inclusion
Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.
Measured: On the 1 day of inclusion
Mortality
Measured: at 28 days
Length of stay in intensive care unit
Measured: Until discharge from the ICU, an average 28 days
Duration of mechanical ventilation
Measured: Until discharge from the ICU, an average 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start28 Aug 2023
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Saad NSEIR, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671328
- Sponsor's protocol ID
- 2022_0061
- Other IDs
- 2022-A00496-37
- Acronym
- ASPIC
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2022
- Last updated
- 26 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Invasive Pulmonary Aspergillosis in Patients With Suspected Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT05671328
- Acronym / sponsor ID
- ASPIC / 2022_0061
- Keywords
- Pulmonary invasive aspergillosis, ventilator-associated-pneumonia, mechanical ventilation, nosocomial infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 4 Jan 2023 (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.
Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected ventilator-associated pneumonia | – | Other: Biological examinations performed on blood and BAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in ICU
Key inclusion criteria (6 listed)
- Adult patient (age ≥ 18 years),
- On invasive ventilation for more than 48 hours,
- Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria:
Key exclusion criteria (3 listed)
- Neutropenic patients (neutrophils < 0.5G/L),
- Previous diagnosis of IPA,
- Minor patients.
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 |
|---|---|---|
| Biological examinations performed on blood and BALDirect examination and culture of BAL Galactomannan in serum and BAL Serum 1,3 beta D glucans Aspergillus PCR in BAL | Other | Patients with suspected ventilator-associated pneumonia |
Primary outcome
Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
Time frame: On the 1 day of inclusion
6 secondary outcomes
Incidence of IPA according to the Blot criteria
Time frame: On the 1 day of inclusion
Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria
Time frame: On the 1 day of inclusion
Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.
Time frame: On the 1 day of inclusion
Mortality
Time frame: at 28 days
Length of stay in intensive care unit
Time frame: Until discharge from the ICU, an average 28 days
Duration of mechanical ventilation
Time frame: Until discharge from the ICU, an average 28 days
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 26 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.
Saad NSEIR, MD,PhD principal investigator
University Hospital, Lille
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 Ventilator Associated Pneumonia and Pulmonary Aspergillosis Invasive, run by University Hospital, Lille 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 6 inclusion and 3 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 26 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 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?
Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP (time frame: On the 1 day of inclusion). 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 26 Dec 2025.