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

U

University Hospital, Lille

Status

Enrolling

Conditions

Immunodeficiency
Pneumonia, Hospital-Acquired
Pneumonia, Ventilator-Associated

Treatments

Other: Standard care
Other: PCR based strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT05405491
2021-A02900-41 (Other Identifier)
2021_0344

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 2 patient groups

PCR group
Experimental group
Treatment:
Other: PCR based strategy
Control group
Sham Comparator group
Treatment:
Other: Standard care

Trial contacts and locations

1

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Central trial contact

Marion HOUARD, MD

Data sourced from clinicaltrials.gov

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