Ventilator-associated Pneumonia Clinical Trial
— AB-DIRECT2Official title:
Impact of Susceptibility Testing Directly on the Deep Respiratory Samples of Patients Suspected Pneumonia Ventilator ( VAP ) Late ( > 5 Days) in Intensive Care Unit on the Adequacy of Antibiotic Treatment to Carbapenems Sparing on Day 1
Inappropriate antibiotic therapy in ventilator-associated pneumonia (VAP) is associated with
increased mortality. The international guidelines recommend using broad spectrum
antimicrobials especially in patients who received previous antimicrobials, with risk factors
of muti-drug resistant (MDR) VAP or after 5 days of mechanical ventilation. Using
broad-spectrum antibiotics for 48h until the results of conventional cultures and
antimicrobial susceptibility testing (AST) are available, may promote the emergence of
drug-resistant bacteria. Exposure to imipenem, as short as 1 to 3 days, is associated with a
5-fold increase in the risk of imipenem resistance in the gut microbiota of ICU patients
(Armand-Lefevre AAC 2013). Performing AST directly on clinical respiratory samples would
hasten the process by at least 24h.
The diagnostic performance of a rapid method combining mass spectrometry and direct AST
[DAST] are previously analyzed, and compared it with the conventional method (mass
spectrometry with conventional AST [CAST]) and its potential impact was assessed on
antimicrobial use in 85 patients (Le DORZE M et al - Clin. Microbiol. Infect. 2015).
The results produced by the dast were useable in 85,9% of the cases and the sensitivity and
negative predictive values of DAST were 100% for all antibiotics tested, except gentamicin
(97.1% [95%CI = 93.3-101] and 97.4% [93.7-101], respectively) and amikacin (88.9% [81.7-96.1]
and 96.4% [92.1-100.7], respectively), compared with CAST. Specificity and positive
predictive values ranged from 82.9 (74.2-91.5) to 100%, and from 86.4 (78.5−94.2) to 100%,
respectively. If results had been reported to the clinicians, that DAST would have saved
carbapenem prescription in 17 cases (22%) and would have allowed immediate narrow spectrum
antimicrobials in 35/85 (41.2%) cases. But, the benefit of DAST was based on a simulation and
should be now tested in a randomized fashion. This project is a prospective multicenter
study. The hypothesis is that, DAST compared to CAST, would increase the number of adequate
antimicrobial therapy within 24 hours in case of late VAP (> 5 days under mechanical
ventilation) with Gram negative bacilli (GNB) in IC patients while sparing carbapenems
(imipenem and meropenem). The primary objective is to determine the impact of a strategy
using DAST on the rate of day1 adequate therapy without carbapenems in case of late VAP due
to GNB.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | January 30, 2020 |
Est. primary completion date | July 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults (18 years or older) - Need for mechanical ventilation expected for at least 5 days at any time during the ICU stay (including if the intubation was performed before the ICU admission) - VAP suspected and clinical respiratory samples with GNB at direct smear examination - At least one condition with a risk factor of multidrug resistant infection: 1. Previous use of antimicrobials (at least 2 days in the past 7 days) 2. Risk of colonization or infection with MDR or XDR bacteria within 3 months - Written informed consent has to be obtained from the patients or a surrogate. The patient or his surrogate can withdraw from the study at any time. Exclusion Criteria: - Pregnant or lactating women - VAP suspected and respiratory samples without GNB at direct smear examination - VAP that occurred without neither previous antimicrobial exposure in the past 5 days or neither risk of MDR colonization - Samples send to the lab during night and weekend in center if respiratory samples are not performed during this period - Active therapeutic limitation - Known allergy to antibiotics - Social welfare unavailable |
Country | Name | City | State |
---|---|---|---|
France | Bichat Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients with an adequate antimicrobial therapy without carbapenem (imipenem, meropenem) at Day 1 | The proportion of patients with an adequate antimicrobial therapy without carbapenem (imipenem, meropenem) at Day 1 | 2 days | |
Secondary | The proportion of patients with an adequate antimicrobial therapy at Day1 | The proportion of patients with an adequate antimicrobial therapy at Day1 | 2 days | |
Secondary | The number of days alive without carbapenem between day 1 and day 28 | The number of days alive without carbapenem between day 1 and day 28 | 28 days | |
Secondary | The number of days alive without a broad spectrum antibiotic therapy between day 1 and day 28 | The number of days alive without a broad spectrum antibiotic therapy between day 1 and day 28 | 28 days | |
Secondary | The proportion of patients with a de-escalation at Day 1 according to previous definition (Weiss et al.) | The proportion of patients with a de-escalation at Day 1 according to previous definition (Weiss et al.) | 2 day | |
Secondary | The proportion of patients with a relapse or a new VAP occured between day 1 and day 28 | The proportion of patients with a relapse or a new VAP occured between day 1 and day 28 | 28 days | |
Secondary | The proportion of patients with a multidrug-resistant bacteria isolated from clinical or screening samples between day 1 and day 28 | The proportion of patients with a multidrug-resistant bacteria isolated from clinical or screening samples between day 1 and day 28 | 28 days | |
Secondary | Evolution of the CPIS score between day 1 and day 28 | The Clinical Pulmonary Infection Score (CPIS) is calculated with the following parameters : Temperature (Celsius) White Blood Cell Count Tracheal Secretions PaO2/FiO2 Chest Radiograph |
28 days | |
Secondary | Evolution of the PaO2/FiO2 ratio between day 1 and day 28 | Evolution of the PaO2/FiO2 ratio between day 1 and day 28 | 28 days | |
Secondary | Evolution of the SOFA score between day 1 and day 28 | The Sequential Organ Failure Assessment (SOFA) score is calculated with the combination of 6 scores. respiratory score with the parameter PaO2/FiO2 neurological score with the Glasgow scale cardiovascular score with Mean arterial pressure parameter hepatic score with bilirubin parameter coagulation score with measure of platelets renal score with creatinine parameter |
28 days | |
Secondary | The number of days alive without mechanical ventilation between day 1 and day 28 | The number of days alive without mechanical ventilation between day 1 and day 28 | 28 days | |
Secondary | The length of ICU stay | The length of ICU stay | 28 days | |
Secondary | ICU-mortality at day 28 | ICU-mortality at day 28 | 28 days | |
Secondary | The proportion of concordant antibiotic susceptibility results between DAST and CAST | Accuracy of the DAST. Sensitivity, specificity, positive predictive value, negative predictive value | 2 days | |
Secondary | Cost minimization because of the DAST strategy | The consumed resources considered will be evaluated for each strategy | 2 days |
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