Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05405491
Other study ID # 2021_0344
Secondary ID 2021-A02900-41
Status Recruiting
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date September 2024

Study information

Verified date May 2023
Source University Hospital, Lille
Contact Marion HOUARD, MD
Phone 0320445962
Email marion.houard@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV Exclusion Criteria: - No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study

Study Design


Intervention

Other:
PCR based strategy
Early adjustment of antimicrobial therapy according to the results of a multiplex PCR-based testing, used in addition to standard microbiological culture of the tracheal aspirate, in immunocompromised patients with suspected VAP or HAP requiring MV
Standard care
Broad-spectrum antimicrobial therapy adjustment after results of standard microbiological culture of the tracheal aspirate in immunocompromised patients with suspected VAP or HAP requiring MV

Locations

Country Name City State
France Houard Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in percentage of patients with targeted antibiotics To determine the impact of a PCR-based strategy on the increase in percentage of patients with targeted antibiotics regimen 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care 24 hours after the initiation of empiric antimicrobial therapy
Secondary Percentage of patients receiving appropriate anticrobial treatment To determine the impact of a PCR-based strategy on the percentage of patients receiving approriate antimicrobial treatment 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care 24 hours after the initiation of empiric antimicrobial therapy
Secondary Mechanical ventilation free days To determine the impact of a PCR-based strategy on the amount of days alive and free from mechanical ventilation at day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care 28 days after the initiation of empiric antimicrobial therapy
Secondary ICU Length of stay To determine the impact of a PCR-based strategy on the length of stay in the Intensive Care Unit in the experimental group compared to standard care Until 28 days after the initiation of empiric antimicrobial therapy
Secondary 28 days mortality To determine the impact of a PCR-based strategy on the mortality at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care 28 days after the initiation of empiric antimicrobial therapy
Secondary Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria To determine the impact of a PCR-based strategy on the incidence of ICU-acquired infections and ICU-acquired colonization involving multidrug resistant bacteria at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care 28 days after the initiation of empiric antimicrobial therapy
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06370598 - Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia Phase 1/Phase 2
Terminated NCT02806141 - Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates Phase 3
Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT00521677 - Comparison Between Two Methods of Oral Care on the Incidence of VAP N/A
Completed NCT00529776 - Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy N/A
Completed NCT03401463 - Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar N/A
Completed NCT02950519 - Endotracheal Tube Cuff Pressures in Ventilated Patients N/A
Completed NCT01875692 - Can we Better Understand the Development of VAP and Eventually Predict and Prevent it? N/A
Completed NCT00515034 - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia Phase 2
Recruiting NCT05117125 - Biomarkers for Ventilator-associated Pneumonia
Completed NCT04755972 - Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2 N/A
Terminated NCT02940626 - Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus. Phase 2
Completed NCT01577862 - Colistin and Rifampicin for MDR-Acinetobacter Phase 3
Completed NCT00572559 - Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus Phase 4
Withdrawn NCT04566172 - Preoperative Optimization to Improve Functional Status N/A
Recruiting NCT04215692 - Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients N/A
Completed NCT03816956 - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 Phase 3
Active, not recruiting NCT01123681 - Intubation and Extubation Over 48 Hours Mechanical Ventilation N/A
Recruiting NCT04839653 - Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria N/A
Recruiting NCT03527992 - Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia N/A