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CompletedNCT06428318Updated May 29, 2024

Diagnostic Value of the Biofire®in Community Acquired Pneumonia

An interventional study of Conventional Sputum culture and BioFire Pneumonia Panel (BFPP) in Pneumonia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pneumonia

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients admitted to the ICU with community acquired pneumonia

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group A: Routine Conventional Methods

    Patients subjected to Routine sputum culture Conventional Methods

    Diagnostic Test: Conventional Sputum culture

  • Active comparator
    GroupB: BioFire Pneumonia Panel (BFPP).

    Patients subjected to BioFire Pneumonia Panel (BFPP

    Diagnostic Test: BioFire Pneumonia Panel (BFPP)

Interventions

  • Diagnostic testConventional Sputum culture

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

  • Diagnostic testBioFire Pneumonia Panel (BFPP)

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

06

What researchers measure

Primary outcomes

  1. the ICU length of stay

    The potential correlation between the use of BFPP and its relation to the ICU length of stay

    Time frame: Five days after admission

07

Study locations

1 site
  • Ain Shams University
    Cairo, Abassia, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06428318
Lead sponsor
Ain Shams University
Responsible party
Rania Maher Hussien, MD (Associate Professor, Ain Shams University) — Principal investigator
First posted
May 24, 2024
Start date
May 15, 2023
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
May 29, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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