Diagnostic Value of the Biofire®in Community Acquired Pneumonia

NCT ID: NCT06428318

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A: Routine Conventional Methods

Patients subjected to Routine sputum culture Conventional Methods

Group Type ACTIVE_COMPARATOR

Conventional Sputum culture

Intervention Type DIAGNOSTIC_TEST

Sputum culture was done to patients and they received Antibiotics According to its results

GroupB: BioFire Pneumonia Panel (BFPP).

Patients subjected to BioFire Pneumonia Panel (BFPP

Group Type ACTIVE_COMPARATOR

BioFire Pneumonia Panel (BFPP)

Intervention Type DIAGNOSTIC_TEST

BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results

Interventions

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Conventional Sputum culture

Sputum culture was done to patients and they received Antibiotics According to its results

Intervention Type DIAGNOSTIC_TEST

BioFire Pneumonia Panel (BFPP)

BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rania Maher Hussien, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, Abassia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS267/2023

Identifier Type: -

Identifier Source: org_study_id

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