NCT02897466: AB-DIRECT2

Impact of Direct Antimicrobial Susceptibility Testing on Respiratory Sample of Intensive Care Patient With Suspected VAP

Status unknown NA Last updated 15 October 2018

What this trial tests

NA trial testing Direct Antimicrobial Susceptibility Testing in Ventilator-associated Pneumonia in 180 participants. Status unknown.

Timeline

11 December 2017

Primary endpoint
11 July 2019

30 January 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	180
Start date	11 December 2017
Primary completion	11 July 2019
Estimated completion	30 January 2020
Sites	1 location across France

Drugs / interventions tested

• Direct Antimicrobial Susceptibility Testing

Conditions studied

• Ventilator-associated Pneumonia — all drugs for Ventilator-associated Pneumonia →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Ventilator-associated Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.