- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066736
Risks Factors and Outcome of Recurrences in Patients With Ventilator-Associated Pneumonias (REVAP) (REVAP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Adrien Bouglé, MD
- Phone Number: +33 1 42 16 29 91
- Email: adrien.bougle@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Hôpital La Pitié-Salpêtrière
-
Contact:
- Adrien BOUGLE, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Opposition to the use of personnal data
- People under legal protection (curatorship, guardianship) or safeguard of justice
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with Ventilator-associated pneumonia
Patients having presented an episode of ventilator-associated pneumonia, undergoing invasive mechanical ventilation ≥ 48h
|
No intervention, observational group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days after ICU admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Ventilator-associated pneumonia recurrences
Time Frame: During inclusion period (from 01JAN2021 to 31DEC2022)
|
Number of Ventilator-associated pneumonia recurrences during ICU stay
|
During inclusion period (from 01JAN2021 to 31DEC2022)
|
Number of days without mechanical ventilation at D28
Time Frame: 28 days after ICU admission
|
Number of days without mechanical ventilation at D28
|
28 days after ICU admission
|
Number of days without renal replacement therapy at D28
Time Frame: 28 days after ICU admission
|
Number of days without renal replacement therapy at D28
|
28 days after ICU admission
|
Number of days without catecholamines at D28
Time Frame: 28 days after ICU admission
|
Number of days without catecholamines at D28
|
28 days after ICU admission
|
Number of days without antibiotics at D28
Time Frame: 28 days after ICU admission
|
Number of days without antibiotics at D28
|
28 days after ICU admission
|
MDR acquisition rate
Time Frame: During ICU stay
|
multiresistant bacteriaacquisition rate
|
During ICU stay
|
Length of stay in intensive care unit
Time Frame: During inclusion period (from 01JAN2021 to 31DEC2022)
|
Length of stay in intensive care unit
|
During inclusion period (from 01JAN2021 to 31DEC2022)
|
Length of hospital stay
Time Frame: During inclusion period (from 01JAN2021 to 31DEC2022)
|
Length of hospital stay
|
During inclusion period (from 01JAN2021 to 31DEC2022)
|
Number of persistent Ventilator-associated pneumonia
Time Frame: During inclusion period (from 01JAN2021 to 31DEC2022)
|
Number of persistent Ventilator-associated pneumonia
|
During inclusion period (from 01JAN2021 to 31DEC2022)
|
Number of superinfections of Ventilator-associated pneumonia
Time Frame: During inclusion period (from 01JAN2021 to 31DEC2022)
|
Number of superinfections of Ventilator-associated pneumonia
|
During inclusion period (from 01JAN2021 to 31DEC2022)
|
Collaborators and Investigators
Investigators
- Study Chair: Adrien Bouglé, MD, Hôpital La Pitié-Salpêtrière
Publications and helpful links
General 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.
- Combes 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REVAP / 2022-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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