Diagnostic Value of the Biofire®in Community Acquired Pneumonia

May 26, 2024 updated by: Rania Maher Hussien, MD, Ain Shams University

Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abassia
      • Cairo, Abassia, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Routine Conventional Methods
Patients subjected to Routine sputum culture Conventional Methods
Diagnostic test: Conventional Sputum culture
Sputum culture was done to patients and they received Antibiotics According to its results
Active Comparator: GroupB: BioFire Pneumonia Panel (BFPP).
Patients subjected to BioFire Pneumonia Panel (BFPP
Diagnostic test: BioFire Pneumonia Panel (BFPP)
BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the ICU length of stay
Time Frame: Five days after admission
The potential correlation between the use of BFPP and its relation to the ICU length of stay
Five days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS267/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on Conventional Sputum culture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe