Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation

NCT05405491 | Active Not Recruiting

• 2 other identifiers: 2021_03442021-A02900-41
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Hospital-Acquired; Immunodeficiency

Keywords

Ventilator-associated pneumonia; Hospital-acquired pneumonia; Immunodeficiency; Antimicrobial therapy; Polymerase chain reaction (PCR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of patients receiving appropriate anticrobial treatment

  24 hours after the initiation of empiric antimicrobial therapy

• Mechanical ventilation free days

  28 days after the initiation of empiric antimicrobial therapy

• ICU Length of stay

  Until 28 days after the initiation of empiric antimicrobial therapy

• 28 days mortality

  28 days after the initiation of empiric antimicrobial therapy

• Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria

  28 days after the initiation of empiric antimicrobial therapy

Study Arms (2)

PCR group

EXPERIMENTAL

Other: PCR based strategy

Control group

SHAM COMPARATOR

Other: Standard care

Interventions

Standard care OTHER

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

Control group

PCR based strategy OTHER

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

PCR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV

You may not qualify if:

• No immunodeficiency Moribund patients (SAPS II \> 90) Pregnant women Refuse to participate to the study

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Houard

Lille, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Immunologic Deficiency Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marion HOUARD, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: March 28, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)