Diagnostic Value of the Biofire®in Community Acquired Pneumonia

Not Applicable

Completed

• Conditions: Pneumonia
• Interventions: Diagnostic Test: Conventional Sputum culture; Diagnostic Test: BioFire Pneumonia Panel (BFPP)

• Registration Number: NCT06428318
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-05-15
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-24
• Last Update Submitted: 2024-05-26
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Routine Conventional Methods	Conventional Sputum culture	Patients subjected to Routine sputum culture Conventional Methods
GroupB: BioFire Pneumonia Panel (BFPP).	BioFire Pneumonia Panel (BFPP)	Patients subjected to BioFire Pneumonia Panel (BFPP

Primary Outcome Measures

Name	Time	Method
the ICU length of stay	Five days after admission	The potential correlation between the use of BFPP and its relation to the ICU length of stay

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abassia, Egypt