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Diagnostic Value of the Biofire®in Community Acquired Pneumonia

A

Ain Shams University

Status

Completed

Conditions

Pneumonia

Treatments

Diagnostic Test: Conventional Sputum culture
Diagnostic Test: BioFire Pneumonia Panel (BFPP)

Study type

Interventional

Funder types

Other

Identifiers

NCT06428318
FMASU MS267/2023

Details and patient eligibility

About

This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia.

Full description

the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach.

This study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients admitted to the ICU with community acquired pneumonia

Exclusion criteria

  • Age less than 18 years old.
  • End stage malignant patients,
  • Patients admitted to the ICU with Acute Lung Injury (ALI).
  • Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS).
  • Patients with radiological findings suggesting atypical pneumonia.
  • Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids > 20mg/day Prednisone equivalent, other immunosuppressants.
  • Solid organ or bone marrow transplant patients, cystic fibrosis.
  • Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Group A: Routine Conventional Methods
Active Comparator group
Description:
Patients subjected to Routine sputum culture Conventional Methods
Treatment:
Diagnostic Test: Conventional Sputum culture
GroupB: BioFire Pneumonia Panel (BFPP).
Active Comparator group
Description:
Patients subjected to BioFire Pneumonia Panel (BFPP
Treatment:
Diagnostic Test: BioFire Pneumonia Panel (BFPP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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