NCT06428318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 21, 2024

Last Update Submit

May 26, 2024

Conditions

Outcome Measures

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

    Five days after admission

Study Arms (2)

Group A: Routine Conventional Methods

ACTIVE COMPARATOR

Patients subjected to Routine sputum culture Conventional Methods

Diagnostic Test: Conventional Sputum culture

GroupB: BioFire Pneumonia Panel (BFPP).

ACTIVE COMPARATOR

Patients subjected to BioFire Pneumonia Panel (BFPP

Diagnostic Test: BioFire Pneumonia Panel (BFPP)

Interventions

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

Group A: Routine Conventional Methods

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

GroupB: BioFire Pneumonia Panel (BFPP).

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the ICU with community acquired pneumonia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abassia, Egypt

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 24, 2024

Study Start

May 15, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations