Ventilator-associated PneumoniaREVAPNCT06066736
Risks Factors and Outcome of Recurrences in Patients With Ventilator-Associated Pneumonias (REVAP)
An observational study of Ventilator-associated Pneumonia, run by Société Française d'Anesthésie et de Réanimation at 1 site in France.
Trial summary
Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- observational
- How many people
- 1,569 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 26 Feb 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: Adults patients having presented an episode of ventilator-associated pneumonia
Who may be able to join
- Adult patient
- Having presented an episode of ventilator-associated pneumonia defined as the association in a patient undergoing invasive mechanical ventilation ≥ 48h:
- Radiological signs: two successive chest X-rays showing new or progressive pulmonary infiltrates (in the absence of a medical history of underlying heart or lung disease, a single chest X-ray is sufficient).
- And at least one of the following signs:
- Fever > 38.0˚ C without any other cause
- Leukocytes < 4 × 109 l-1 or > 12 × 109 l-1
Show all 11Show fewer
- And at least two of the following signs:
- Purulent tracheobronchial secretions
- Cough or dyspnea
- Decreased oxygenation or increased oxygen requirements, or need for respiratory assistance
- Patient does not object to the use of his/her data for this research
Who cannot join
- Opposition to the use of personnal data
- People under legal protection (curatorship, guardianship) or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU .
In fact, these recurrences can be linked to:
Read more
- Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
- Inappropriate initial antibiotic therapy (type, duration and dose administered),
- Characteristics specific to the pathogens encountered (virulence factors or resistance),
- Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).
Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.
The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.
An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial, which is currently undergoing enrolment.
The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.
Read the detailed description
Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU (1,2).
In fact, these recurrences can be linked to:
- Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
- Inappropriate initial antibiotic therapy (type, duration and dose administered),
- Characteristics specific to the pathogens encountered (virulence factors or resistance),
- Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).
Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.
The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.
An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial (3), which is currently undergoing enrolment.
The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.
- Combes A, Figliolini C, Trouillet J-L, Kassis N, Dombret M-C, Wolff M, et al. Factors predicting ventilator-associated pneumonia recurrence. Crit Care Med. 2003 Apr;31(4):1102-1107.
- Combes A, Luyt C-E, Fagon J-Y, Wolff M, Trouillet J-L, Chastre J, et al. Early predictors for infection recurrence and death in patients with ventilator-associated pneumonia. Crit Care Med. 2007 Jan;35(1):146-154.
- Foucrier A, Roquilly A, Bachelet D, Martin-Loeches I, Bougle A, Timsit JF, Montravers P, Zahar JR, Eloy P, Weiss E; ASPIC study group. Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for a randomised controlled trial. BMJ Open. 2023 Feb 21;13(2):e065293. doi: 10.1136/bmjopen-2022-065293. PMID: 36810173; PMCID: PMC9944671.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- observational
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
No intervention, observational group
| Study group | Role | What they receive |
|---|---|---|
| Patients with Ventilator-associated pneumonia | Patients having presented an episode of ventilator-associated pneumonia, undergoing invasive mechanical ventilation ≥ 48h Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 28 days
Mortality at 28 days, verify if patient died 28 days after Ventilator-associated pneumonia
Measured: 28 days after ICU admission
Secondary outcomes (10)
Number of Ventilator-associated pneumonia recurrences
Number of Ventilator-associated pneumonia recurrences during ICU stay
Measured: During inclusion period (from 01JAN2021 to 31DEC2022)
Number of days without mechanical ventilation at day 28
Number of days without mechanical ventilation at day 28
Measured: 28 days after ICU admission
Number of days without renal replacement therapy at day 28
Number of days without renal replacement therapy at day 28
Measured: 28 days after ICU admission
Number of days without catecholamines at day 28
Number of days without catecholamines at day 28
Measured: 28 days after ICU admission
Number of days without antibiotics at day 28
Number of days without antibiotics at day 28
Measured: 28 days after ICU admission
MDR acquisition rate
multiresistant bacteriaacquisition rate
Measured: During ICU stay
Length of stay in intensive care unit
Length of stay in intensive care unit
Measured: During inclusion period (from 01JAN2021 to 31DEC2022)
Length of hospital stay
Length of hospital stay
Measured: During inclusion period (from 01JAN2021 to 31DEC2022)
Number of persistent Ventilator-associated pneumonia
Number of persistent Ventilator-associated pneumonia
Measured: During inclusion period (from 01JAN2021 to 31DEC2022)
Number of superinfections of Ventilator-associated pneumonia
Number of superinfections of Ventilator-associated pneumonia
Measured: During inclusion period (from 01JAN2021 to 31DEC2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Dec 2023
- Primary completion31 Aug 2024
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- 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
- 1,569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien Bouglé, MD, Study chair, Hôpital La Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066736
- Sponsor's protocol ID
- REVAP / 2022-11
- Acronym
- REVAP
- Status last verified
- May 2025
- First submitted
- 27 Sep 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: unplanned for the moment
Publications
Combes A, Figliolini C, Trouillet JL, Kassis N, Dombret MC, Wolff M, Gibert C, Chastre J. Factors predicting ventilator-associated pneumonia recurrence. Crit Care Med. 2003 Apr;31(4):1102-7. doi: 10.1097/01.CCM.0000059313.31477.2C.
PubMed 12682479Combes A, Luyt CE, Fagon JY, Wolff M, Trouillet JL, Chastre J. Early predictors for infection recurrence and death in patients with ventilator-associated pneumonia. Crit Care Med. 2007 Jan;35(1):146-54. doi: 10.1097/01.CCM.0000249826.81273.E4.
PubMed 17080004Foucrier A, Roquilly A, Bachelet D, Martin-Loeches I, Bougle A, Timsit JF, Montravers P, Zahar JR, Eloy P, Weiss E; ASPIC study group. Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for a randomised controlled trial. BMJ Open. 2023 Feb 21;13(2):e065293. doi: 10.1136/bmjopen-2022-065293.
PubMed 36810173
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks Factors and Outcome of Recurrences in Patients With Ventilator-Associated Pneumonias (REVAP)
- ClinicalTrials.gov ID
- NCT06066736
- Acronym / sponsor ID
- REVAP / REVAP / 2022-11
- Conditions
- Ventilator-associated Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,569 participants (actual)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 4 Oct 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.
Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU .
In fact, these recurrences can be linked to:
- Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
- Inappropriate initial antibiotic therapy (type, duration and dose administered),
- Characteristics specific to the pathogens encountered (virulence factors or resistance),
- Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).
Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.
The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.
An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial, which is currently undergoing enrolment.
The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.
Detailed description
Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU (1,2).
In fact, these recurrences can be linked to:
- Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
- Inappropriate initial antibiotic therapy (type, duration and dose administered),
- Characteristics specific to the pathogens encountered (virulence factors or resistance),
- Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).
Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.
The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.
An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial (3), which is currently undergoing enrolment.
The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.
- Combes A, Figliolini C, Trouillet J-L, Kassis N, Dombret M-C, Wolff M, et al. Factors predicting ventilator-associated pneumonia recurrence. Crit Care Med. 2003 Apr;31(4):1102-1107.
- Combes A, Luyt C-E, Fagon J-Y, Wolff M, Trouillet J-L, Chastre J, et al. Early predictors for infection recurrence and death in patients with ventilator-associated pneumonia. Crit Care Med. 2007 Jan;35(1):146-154.
- Foucrier A, Roquilly A, Bachelet D, Martin-Loeches I, Bougle A, Timsit JF, Montravers P, Zahar JR, Eloy P, Weiss E; ASPIC study group. Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for a randomised controlled trial. BMJ Open. 2023 Feb 21;13(2):e065293. doi: 10.1136/bmjopen-2022-065293. PMID: 36810173; PMCID: PMC9944671.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Ventilator-associated pneumonia | – | Other: observationalPatients having presented an episode of ventilator-associated pneumonia, undergoing invasive mechanical ventilation ≥ 48h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients having presented an episode of ventilator-associated pneumonia
Key inclusion criteria (11 listed)
- Adult patient
- Having presented an episode of ventilator-associated pneumonia defined as the association in a patient undergoing invasive mechanical ventilation ≥ 48h:
- Patient does not object to the use of his/her data for this research
Key exclusion criteria (2 listed)
- Opposition to the use of personnal data
- People under legal protection (curatorship, guardianship) or safeguard of justice
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 |
|---|---|---|
| observationalNo intervention, observational group | Other | Patients with Ventilator-associated pneumonia |
Primary outcome
Mortality at 28 days
Time frame: 28 days after ICU admission
Mortality at 28 days, verify if patient died 28 days after Ventilator-associated pneumonia
10 secondary outcomes
Number of Ventilator-associated pneumonia recurrences
Time frame: During inclusion period (from 01JAN2021 to 31DEC2022)
Number of days without mechanical ventilation at day 28
Time frame: 28 days after ICU admission
Number of days without renal replacement therapy at day 28
Time frame: 28 days after ICU admission
Number of days without catecholamines at day 28
Time frame: 28 days after ICU admission
Number of days without antibiotics at day 28
Time frame: 28 days after ICU admission
MDR acquisition rate
Time frame: During ICU stay
Length of stay in intensive care unit
Time frame: During inclusion period (from 01JAN2021 to 31DEC2022)
Length of hospital stay
Time frame: During inclusion period (from 01JAN2021 to 31DEC2022)
Number of persistent Ventilator-associated pneumonia
Time frame: During inclusion period (from 01JAN2021 to 31DEC2022)
Number of superinfections of Ventilator-associated pneumonia
Time frame: During inclusion period (from 01JAN2021 to 31DEC2022)
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 14 May 2025.
- Background: PubMed 12682479Combes A, Figliolini C, Trouillet JL, Kassis N, Dombret MC, Wolff M, Gibert C, Chastre J. Factors predicting ventilator-associated pneumonia recurrence. Crit Care Med. 2003 Apr;31(4):1102-7. doi: 10.1097/01.CCM.0000059313.31477.2C.
- Background: PubMed 17080004Combes A, Luyt CE, Fagon JY, Wolff M, Trouillet JL, Chastre J. Early predictors for infection recurrence and death in patients with ventilator-associated pneumonia. Crit Care Med. 2007 Jan;35(1):146-54. doi: 10.1097/01.CCM.0000249826.81273.E4.
- Background: PubMed 36810173Foucrier A, Roquilly A, Bachelet D, Martin-Loeches I, Bougle A, Timsit JF, Montravers P, Zahar JR, Eloy P, Weiss E; ASPIC study group. Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for a randomised controlled trial. BMJ Open. 2023 Feb 21;13(2):e065293. doi: 10.1136/bmjopen-2022-065293.
- Individual participant dataSharing planned: Undecided. unplanned for the moment
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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.
Adrien Bouglé, MD study chair
Hôpital La Pitié-Salpêtrière
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, run by Société Française d'Anesthésie et de Réanimation 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 2 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 14 May 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?
Mortality at 28 days (time frame: 28 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066736, which also lists 3 linked publications.
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 14 May 2025.