Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care Acronym: ASPIC - ASPIC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002197-78-FR

Enrollment

590

Registered

2022-01-18

Start date

2021-08-19

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventilator associated neumonia in intensive care

Interventions

Trade Name: ciprofloxacine Kabi Axepim Istopen Piperacilline amikacine ceftazidime claventin céfotaxime getamicine tavanic tazocilline tienam Augmentin clamoxyl meronem Pharmaceutical Form: Solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patient is =18 and - Patient under MV - Diagnosis of microbiologically confirmed of first episode of VAP - Initial adequate empiric antibiotic therapy -Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 590 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 590

Exclusion criteria

Exclusion criteria: Patient under selective decontamination of the digestive tract - Concomitant extra-respiratory infection requiring antibiotic therapy at the moment of inclusion - Inclusion in another interventional study concerning antimicrobial strategies - Moribund (IGS II>80) - Thoracic trauma with Abbreviated Injury Scale (AIS) thorax ? 3 - Severely immunocompromised patients (such as congenital immunodeficiency , neutropenia (<1leucocyte/ml or <0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below 200/mm3 - VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant Enterobacteriaceae - Bacterial VAP in a context of COVID-19 or other confirmed viral pneumonia - No health insurance coverage

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.;Secondary Objective: To investigate if an antimicrobial stewardship for VAP based on daily assessment of clinical cure, if it is obtained, would be non-inferior in term of all-cause mortality and of occurrence of treatment failure, of occurrence of occurrence of new episode of pneumonia, increase the number of antibiotic free-alive days, from initiation of VAP antibiotic therapy to day 28, reduce at day 28, of VAP antibiotic therapy the global DOOR score and RADAR, reduce at day 28, the duration of invasive mechanical ventilation, reduce at day 28 after inclusion the length of stay in intensive care unit,reduce at day 28, the rate of VAP recurrence, reduce at day 28 the rate of complications of antibiotic therapy, symptoms, acute kidney injury, skin reactions and other drug-specific adverse12, reduce at day 28: the rate of acquisition of carriage of MDR bacteria,The rate of subsequent infection. ;Primary end point(s): The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment;Timepoint(s) of evaluation of this end point: day 28	—

Measure

Time frame

Main Objective: The aim of this study is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.;Secondary Objective: To investigate if an antimicrobial stewardship for VAP based on daily assessment of clinical cure, if it is obtained, would be non-inferior in term of all-cause mortality and of occurrence of treatment failure, of occurrence of occurrence of new episode of pneumonia, increase the number of antibiotic free-alive days, from initiation of VAP antibiotic therapy to day 28, reduce at day 28, of VAP antibiotic therapy the global DOOR score and RADAR, reduce at day 28, the duration of invasive mechanical ventilation, reduce at day 28 after inclusion the length of stay in intensive care unit,reduce at day 28, the rate of VAP recurrence, reduce at day 28 the rate of complications of antibiotic therapy, symptoms, acute kidney injury, skin reactions and other drug-specific adverse12, reduce at day 28: the rate of acquisition of carriage of MDR bacteria,The rate of subsequent infection. ;Primary end point(s): The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment;Timepoint(s) of evaluation of this end point: day 28

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Secondary

Measure	Time frame
Secondary end point(s): 1) Rate of all-cause mortality 2) Rate of treatment failure 3) Rate of new episode of VAP 4) Number of antibiotic free alive-days from initiation of VAP antibiotic therapy to day 28 5) Global score constructed with the DOOR and RADAR. Overall clinical outcome at day 28, from most to least desirable are: 1. Survival, clinical cure, no adverse events 2. Survival, clinical cure, antibiotic related side effects 3.Survival, clinical cure, subsequent extrapulmonary infection 4. Survival, clinical cure, subsequent new episode of VAP 5. Death 6) Duration of invasive MV, at day 28 after inclusion, defined as total of days under MV 7) Length of ICU stay at day 28 after inclusion, defined by the number of days between inclusion and ICU discharge or in-ICU death. 8) Rate of VAP recurrence by the intensivist at day 28 9) Rate of antibiotic related side effects 10) Rate of acquisition of MDR bacteria at day 28 defined as the identification of a MDR bacteria carriage not present at admission 11) Rate of death at days 28 and 90 at day 28 12) Rate of non-interruption of antibiotic therapy despite a positive clinical cure in the intervention group only at day 28 after inclusion. 13) Total cumulative costs of antibiotics at day 28 and incremental cost effectiveness ratio;Timepoint(s) of evaluation of this end point: day 90	—

Measure

Time frame

Secondary end point(s): 1) Rate of all-cause mortality 2) Rate of treatment failure 3) Rate of new episode of VAP 4) Number of antibiotic free alive-days from initiation of VAP antibiotic therapy to day 28 5) Global score constructed with the DOOR and RADAR. Overall clinical outcome at day 28, from most to least desirable are: 1. Survival, clinical cure, no adverse events 2. Survival, clinical cure, antibiotic related side effects 3.Survival, clinical cure, subsequent extrapulmonary infection 4. Survival, clinical cure, subsequent new episode of VAP 5. Death 6) Duration of invasive MV, at day 28 after inclusion, defined as total of days under MV 7) Length of ICU stay at day 28 after inclusion, defined by the number of days between inclusion and ICU discharge or in-ICU death. 8) Rate of VAP recurrence by the intensivist at day 28 9) Rate of antibiotic related side effects 10) Rate of acquisition of MDR bacteria at day 28 defined as the identification of a MDR bacteria carriage not present at admission 11) Rate of death at days 28 and 90 at day 28 12) Rate of non-interruption of antibiotic therapy despite a positive clinical cure in the intervention group only at day 28 after inclusion. 13) Total cumulative costs of antibiotics at day 28 and incremental cost effectiveness ratio;Timepoint(s) of evaluation of this end point: day 90

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Countries

France

Contacts

Public ContactDRCI

Assistance Publique - Hôpitaux de Paris

laura.blanchet@aphp.fr0033144841732

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026