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Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia (iDIAPASON) (iDIAPASON)

Primary Purpose

Ventilator-Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
8 days of effective antibiotic treatment
15 days of effective antibiotic treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator-Associated Pneumonia focused on measuring Ventilator Associated, Pneumonia, Antibiotic treatment, Pseudomonas aeruginosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years
  • Mechanical ventilation ≥ 48 hours
  • Documented Pseudomonas aeruginosa ventilator-associated pneumonia:

    • Clinical suspicion (≥ two criteria including: fever> 38.5°C,leukocytosis > 10 Giga/L or leukopenia < 4 Giga/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography).
    • Documented Pseudomonas aeruginosa positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >104cfu/ml) or plugged telescopic catheter (significant threshold, >103cfu/ml) or quantitative endotracheal aspirate (significant threshold, >106cfu/ml).
  • Written informed consent
  • Patient affiliated to French social security

Exclusion Criteria:

  • Immunocompromised patients (HIV, immunosuppressive therapy, corticosteroids> 0.5 mg / kg per day for more than a month)
  • Patients receiving antibiotic therapy for extrapulmonary infection
  • Patients in whom a procedure of withdrawing life-sustaining treatment has been established
  • Pregnancy
  • Patients included in another interventional study
  • Chronic pulmonary colonization with Pseudomonas aeruginosa: patients with Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis, with a positive respiratory sample at infra threshold rate for Pseudomonas aeruginosa (ie<103 CFUs/mL for protected specimen brush or <106 CFUs/mL for tracheal aspirate), obtained in the absence of pneumonia or exacerbation during the 6 months before the ICU admission.
  • Patient under guardianship or curatorship

Sites / Locations

  • Anesthesiology and Critical Care Medicine Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

8 days of effective antibiotic treatment

15 days of effective antibiotic treatment

Arm Description

Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against PA of 8 days.

Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against PA of 15 days.

Outcomes

Primary Outcome Measures

A composite endpoint of morbi-mortality combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days).
A composite endpoint combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days). Recurrence will be defined a posteriori by 3 independent experts with predefined criteria: clinical suspicion of VAP (≥ two criteria including: fever> 38.5 ° C, leukocytosis > 10 Giga/L or leukopenia < 4 Giga/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography) associated with a positive quantitative culture of a respiratory sample (bronchoalveolar lavage fluid (significant threshold ≥104 colony-forming units/mL) or plugged telescopic catheter (significant threshold ≥103 colony-forming units/mL) or quantitative endotracheal aspirate distal pulmonary secretion samples (significant threshold ≥106 colony-forming units/mL)).

Secondary Outcome Measures

Measure of mortality rate (%) in the ICU
Measure of morbidity in ICU by duration of mechanical ventilation (days)
Measure of morbidity in ICU by duration of hospitalization in ICU (days)
Acquisition of MDR during the hospitalization in the ICU.
Exposure to antibiotics during the hospitalization in the ICU (days)
Number of extrapulmonary infections during the hospitalization in the ICU
Type of extrapulmonary infections during the hospitalization in the ICU

Full Information

First Posted
November 19, 2015
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02634411
Brief Title
Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia (iDIAPASON)
Acronym
iDIAPASON
Official Title
Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia : a Randomized Controlled Study (iDIAPASON)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2016 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic Society to recommend SD therapy for VAP, with the exception of documented VAP of non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP), due to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of SD therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a higher rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD therapy group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially based on microbiological rather than clinical data, and the higher rate of recurrence observed could rather reflect a higher rate of colonization more than a new infection. Interestingly, a trend for a lower rate of mortality was also observed in the SD group (n=15, 23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly underpowered to detect a difference of mortality between groups. The two strategies were considered as not different, for the risk of mortality in a recent meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains questionable considering the large confidence interval of the risk and the power of these studies. Primary objective and assessment criterion: To assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU. Study Design : Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units participating to the study Research period: Total study duration: 27 months Inclusion period: 24 months Duration of participation for a patient: 90 days
Detailed Description
Ventilator-associated pneumonia (VAP) is a major cause of morbidity and mortality in the ICU, accounting for 25% of infections in intensive care units (Réseau RAISIN 2012). From 1975 to 2003, the incidence of hospital-acquired pneumonia caused by Pseudomonas aeruginosa (PA) has almost doubled, from 9.6% to 18.1%. In a US national large-scale survey, PA was the most frequently isolated gram-negative aerobic bacterium from ICUs (23%) and also the most frequent bacterium isolated from the respiratory tract (31.6%). PA-VAP is associated with a high mortality ranging from 40% up to 69%, and with high rates of recurrence despite adequate antimicrobial therapy. In a large randomized trial regarding the optimal duration of antibiotic therapy in overall VAPs, the rate of recurrence among the subgroup of non-fermenting Gram negative bacilli (NF-GNB) documented VAP varied between 19.0% and 32.8%, according to the randomization arm. Finally, a recently published cohort about 393 PA-VAP in 314 patients, the composite criteria failure treatment (death and recurrence) occured in 112 cases (28.5%). Hypothesis A short duration antibiotherapy (8 days) vs. long duration antibiotherapy (15 days) in treatment of Pseudomonas aeruginosa Ventilator-Associated Pneumonia (PA-VAP) is safe and not associated with an increased mortality or recurrence rate of PA-VAP. The demonstration of this hypothesis could lead to decrease antibiotic exposure during the hospitalization in the Intensive Care Unit (ICU) and in turn reduce the acquisition and the spread of multidrug-resistant pathogens (MDR). Objectives Primary objective To assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in Pseudomonas aeruginosa ventilator-associated pneumonia (PA-VAP) on morbi-mortality at 90 days. Secondary objectives To compare between short and long duration of antibiotics on: mortality in the ICU morbidity in the ICU (mechanical ventilation, duration of hospitalization) exposure and acquisition of MDR during hospitalization number and types of extrapulmonary infections Plan for the research Concise description of the primary and secondary assessment criteria - Primary assessment criterion: A composite endpoint combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days). Recurrence will be defined a posteriori by 3 independent experts with predefined criteria: clinical suspicion of VAP (≥ two criteria including: fever> 38.5°C, leukocytosis > 10 Giga/L or leukopenia < 4 Giga/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography). associated with a positive quantitative culture of a respiratory sample (bronchoalveolar lavage fluid (significant threshold ≥104 colony-forming units/mL) or plugged telescopic catheter (significant threshold ≥103 colony-forming units/mL) or quantitative endotracheal aspirate distal pulmonary secretion samples (significant threshold ≥106 colony-forming units/mL)). Secondary assessment criteria: D30 and D90 mortality rate (%) Morbidity by: Duration of mechanical ventilation (days) Duration of hospitalization in ICU (days) Exposure to antibiotics during the hospitalization in the ICU (days) Number and types of extrapulmonary infections during the hospitalization in the ICU (n) Acquisition of MDR during the hospitalization in the ICU (swab sample of rectum and anterior nares) Description of research methodology Randomized, open-labeled non inferiority trial comparing to parallel groups: 8 days of antibiotic therapy 15 days of antibiotic therapy Antibiotic therapy Antibiotic treatment should be started just after realization of bacteriological sampling, without waiting for the result. The choice of initial antibiotic therapy will be left to the discretion of the physician but will be essentially based on the clinical context, previously antibiotic therapy, the presence or absence of risk factors for MDR (antibiotics or hospitalization in previous 90 days, current hospitalization ≥ 5 days, MV ≥ 5 days, supported in a dialysis center or residency in a nursing home), local epidemiological data, and finally if the patient is already known as being colonized by a MDR. Investigators would be strongly encouraged to convert this initial regimen into a narrow- spectrum therapy, based on culture results. All antibiotics would be withdrawn, either at the end of day 8 or day 15, according to the randomization assignment, except those prescribed for a documented pulmonary infection recurrence before that day. An algorithm for the initial prescription of antibiotics will be established in each ICU, the algorithm will be adapted whenever necessary to changes in the local ecology. Number of centres participating 42 french Intensive Care Units (ICUs)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Associated Pneumonia
Keywords
Ventilator Associated, Pneumonia, Antibiotic treatment, Pseudomonas aeruginosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8 days of effective antibiotic treatment
Arm Type
Experimental
Arm Description
Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against PA of 8 days.
Arm Title
15 days of effective antibiotic treatment
Arm Type
Sham Comparator
Arm Description
Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against PA of 15 days.
Intervention Type
Drug
Intervention Name(s)
8 days of effective antibiotic treatment
Intervention Description
Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive). Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 8 days.
Intervention Type
Drug
Intervention Name(s)
15 days of effective antibiotic treatment
Intervention Description
Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive). Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 15 days.
Primary Outcome Measure Information:
Title
A composite endpoint of morbi-mortality combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days).
Description
A composite endpoint combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days). Recurrence will be defined a posteriori by 3 independent experts with predefined criteria: clinical suspicion of VAP (≥ two criteria including: fever> 38.5 ° C, leukocytosis > 10 Giga/L or leukopenia < 4 Giga/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography) associated with a positive quantitative culture of a respiratory sample (bronchoalveolar lavage fluid (significant threshold ≥104 colony-forming units/mL) or plugged telescopic catheter (significant threshold ≥103 colony-forming units/mL) or quantitative endotracheal aspirate distal pulmonary secretion samples (significant threshold ≥106 colony-forming units/mL)).
Time Frame
90 days after effective antibiotherapy
Secondary Outcome Measure Information:
Title
Measure of mortality rate (%) in the ICU
Time Frame
Day 30 and Day 90 after effective antibiotherapy
Title
Measure of morbidity in ICU by duration of mechanical ventilation (days)
Time Frame
Day 30 and Day 90 after effective antibiotherapy
Title
Measure of morbidity in ICU by duration of hospitalization in ICU (days)
Time Frame
Day 30 and Day 90 after effective antibiotherapy
Title
Acquisition of MDR during the hospitalization in the ICU.
Time Frame
during stay in the ICU : up to 90 days
Title
Exposure to antibiotics during the hospitalization in the ICU (days)
Time Frame
during stay in the ICU : up to 90 days
Title
Number of extrapulmonary infections during the hospitalization in the ICU
Time Frame
during stay in the ICU : up to 90 days
Title
Type of extrapulmonary infections during the hospitalization in the ICU
Time Frame
during stay in the ICU : up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years Mechanical ventilation ≥ 48 hours Documented Pseudomonas aeruginosa ventilator-associated pneumonia: Clinical suspicion (≥ two criteria including: fever> 38.5°C,leukocytosis > 10 Giga/L or leukopenia < 4 Giga/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography). Documented Pseudomonas aeruginosa positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >104cfu/ml) or plugged telescopic catheter (significant threshold, >103cfu/ml) or quantitative endotracheal aspirate (significant threshold, >106cfu/ml). Written informed consent Patient affiliated to French social security Exclusion Criteria: Immunocompromised patients (HIV, immunosuppressive therapy, corticosteroids> 0.5 mg / kg per day for more than a month) Patients receiving antibiotic therapy for extrapulmonary infection Patients in whom a procedure of withdrawing life-sustaining treatment has been established Pregnancy Patients included in another interventional study Chronic pulmonary colonization with Pseudomonas aeruginosa: patients with Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis, with a positive respiratory sample at infra threshold rate for Pseudomonas aeruginosa (ie<103 CFUs/mL for protected specimen brush or <106 CFUs/mL for tracheal aspirate), obtained in the absence of pneumonia or exacerbation during the 6 months before the ICU admission. Patient under guardianship or curatorship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrien Bouglé, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology and Critical Care Medicine Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75571
Country
France

12. IPD Sharing Statement

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Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia (iDIAPASON)

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