PneumoniaNCT06428318
Diagnostic Value of the Biofire®in Community Acquired Pneumonia
A study testing Conventional Sputum culture and BioFire Pneumonia Panel (BFPP) in people with Pneumonia, run by Ain Shams University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Conventional Sputum culture and BioFire Pneumonia Panel (BFPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the ICU with community acquired pneumonia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Pneumonia
- Being tested
- Conventional Sputum culture, BioFire Pneumonia Panel (BFPP)
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Sputum cultureDiagnostic test
Sputum culture was done to patients and they received Antibiotics According to its results
BioFire Pneumonia Panel (BFPP)Diagnostic test
BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results
| Study group | Role | What they receive |
|---|---|---|
| Group A: Routine Conventional Methods | Active comparator | Patients subjected to Routine sputum culture Conventional Methods Receives: Diagnostic Test: Conventional Sputum culture |
| GroupB: BioFire Pneumonia Panel (BFPP). | Active comparator | Patients subjected to BioFire Pneumonia Panel (BFPP Receives: Diagnostic Test: BioFire Pneumonia Panel (BFPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ICU length of stay
The potential correlation between the use of BFPP and its relation to the ICU length of stay
Measured: Five days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 May 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428318
- Sponsor's protocol ID
- FMASU MS267/2023
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT06428318
- Acronym / sponsor ID
- FMASU MS267/2023
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Routine Conventional Methods | Active comparator | Diagnostic Test: Conventional Sputum culturePatients subjected to Routine sputum culture Conventional Methods |
| GroupB: BioFire Pneumonia Panel (BFPP). | Active comparator | Diagnostic Test: BioFire Pneumonia Panel (BFPP)Patients subjected to BioFire Pneumonia Panel (BFPP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the ICU with community acquired pneumonia
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Sputum cultureSputum culture was done to patients and they received Antibiotics According to its results | Diagnostic test | Group A: Routine Conventional Methods |
| BioFire Pneumonia Panel (BFPP)BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results | Diagnostic test | GroupB: BioFire Pneumonia Panel (BFPP). |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Sputum culture and BioFire Pneumonia Panel (BFPP) in people with Pneumonia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ICU length of stay (time frame: Five days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.