Viewing Study NCT06554327



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06554327
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-12

Brief Title: Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens
Sponsor: None
Organization: None

Study Overview

Official Title: Fast Multiplex PCR of Bronchoalveolar Lavage for Antibiotic Stewardship in Ventilator Associated Pneumonia A Multicenter Randomized Controlled Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VAMPAIR
Brief Summary: Ventilator-associated pneumonia VAP remains one of the main nosocomial infections acquired in the intensive care unit ICU VAP is pneumonia occurring 48 hours after intubation Today bronchoalveolar lavage BAL is used for microbiological diagnosis with bacterial culture and antibiotic susceptibility results within 48 to 72 hours Multiplex PCR can detect DNA of a number of bacteriae as well as the presence of resistance genes However its clinical value in the ICU remains to be demonstrated We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP could be an interesting method for clinicians in ICU
Detailed Description: Ventilator-associated pneumonia VAP remains one of the main nosocomial infections acquired in the intensive care unit ICU VAP is pneumonia occurring 48 hours after intubation Today bronchoalveolar lavage BAL is used for microbiological diagnosis with bacterial culture and antibiotic susceptibility results within 48 to 72 hours Multiplex PCR can detect the bacterial DNA of a number of bacteria as well as the presence of resistance genes However its clinical value in the ICU remains to be demonstrated We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP could be an interesting method for clinicians in ICU

The aim of our study is to compare the percentage of appropriate empirical antibiotic therapy in the group benefiting from multiplex PCR on BAL prior to bacterial culture results compared to control group bacterial culture aloneusual management in patients with culture-confirmed VAP

This is a multicenter randomized controlled French study conducted in 8 university intensive care units 2 surgical units 6 medical units in the Grand-Est region of France The multiplex PCR tested here is BioFires FilmArray Pneumonia Panel Plus It is performed solely on per-fibroscopic bronchoalveolar lavage BAL fluids in cases of suspected VAP

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None