Infectious Disease of LungNCT06782607
Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients With Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia With High Risk of Multidrug Resistant Pathogen
A study testing Pneumonia Panel by FilmArray in people with Infectious Disease of Lung and Molecular Diagnosis, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease of Lung, Molecular Diagnosis, Pneumonia
- What is being tested?
- Pneumonia Panel by FilmArray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have received complete information about the research and who have not objected to the use of its data
- Patients with suspected pneumonia infection
Who cannot join
- Active immediate life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
- Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage Acute coronary syndrome
- Cardiogenic shock
- Life-threatening gastrointestinal hemorrhage
- Drug overdose
- Advanced-stage cancer with predicted survival less than 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Siriraj Hospital, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease.
The diagnostic process for pneumonia has become significantly more intricate over the past decade due to the interference of the biological, radiological, and clinical criteria of patients hospitalised in the intensive care unit with the conventional criteria for the diagnosis of severe respiratory diseases. Additionally, patients who are hospitalised in the ICU are at a heightened risk of contracting other associated infections. Consequently, patients are frequently administered antibiotics, whether or not they are effective, as it is challenging to promptly determine the aetiology of their symptoms using conventional methods.
To enhance the diagnostic and therapeutic aspects of their treatment, we implemented a novel syndromic molecular test in our laboratories. This test is designed to expedite and enhance the management of pneumonia and the stewardship of antibiotics. This research will include 80 to 100 adult patients hospitalized in ICU between Feb 2025 and Feb 2027. It will take place within the Siriraj Hospital, Bangkok, Thailand.
Read the detailed description
Not provided
- Conditions
- Infectious Disease of Lung, Molecular Diagnosis, Pneumonia
- Being tested
- Pneumonia Panel by FilmArray
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumonia Panel by FilmArrayDiagnostic test
The Pneumonia Panel comprehensively identifies 33 potential pathogen targets from sputum-like (including endotracheal aspirate) and bronchoalveolar lavage (BAL)-like (including mini-BAL) samples. For 15 of the bacteria, the Pneumonia Panel provides semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pneumonia panel group | Experimental | Pneumonia panel measurement and changing of antimicrobials according to the result of pneumonia panel Receives: Diagnostic Test: Pneumonia Panel by FilmArray |
| No Intervention: Standard of care | No intervention | Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic decision [Time Frame: 24 hours following the FilmArray results]
Antibiotic prescription modification following the FilmArray results as:
No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation
Measured: 24 hours following the FilmArray results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infectious Disease of LungStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhiratha Boonyasiri, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782607
- Sponsor's protocol ID
- 010/2025
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stafylaki D, Maraki S, Vaporidi K, Georgopoulos D, Kontoyiannis DP, Kofteridis DP, Chamilos G. Impact of Molecular Syndromic Diagnosis of Severe Pneumonia in the Management of Critically Ill Patients. Microbiol Spectr. 2022 Oct 26;10(5):e0161622. doi: 10.1128/spectrum.01616-22. Epub 2022 Sep 26.
PubMed 36154180High J, Enne VI, Barber JA, Brealey D, Turner DA, Horne R, Peters M, Dhesi Z, Wagner AP, Pandolfo AM, Stirling S, Russell C, O'Grady J, Swart AM, Gant V, Livermore DM; INHALE Study Group. INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care-study protocol for a multicentre randomised controlled trial. Trials. 2021 Oct 7;22(1):680. doi: 10.1186/s13063-021-05618-6.
PubMed 34620213Kosai K, Akamatsu N, Ota K, Mitsumoto-Kaseida F, Sakamoto K, Hasegawa H, Izumikawa K, Mukae H, Yanagihara K. BioFire FilmArray Pneumonia Panel enhances detection of pathogens and antimicrobial resistance in lower respiratory tract specimens. Ann Clin Microbiol Antimicrob. 2022 Jun 4;21(1):24. doi: 10.1186/s12941-022-00512-8.
PubMed 35659683
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients With Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia With High Risk of Multidrug Resistant Pathogen
- ClinicalTrials.gov ID
- NCT06782607
- Acronym / sponsor ID
- 010/2025
- Conditions
- Infectious Disease of Lung, Molecular Diagnosis, Pneumonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease.
The diagnostic process for pneumonia has become significantly more intricate over the past decade due to the interference of the biological, radiological, and clinical criteria of patients hospitalised in the intensive care unit with the conventional criteria for the diagnosis of severe respiratory diseases. Additionally, patients who are hospitalised in the ICU are at a heightened risk of contracting other associated infections. Consequently, patients are frequently administered antibiotics, whether or not they are effective, as it is challenging to promptly determine the aetiology of their symptoms using conventional methods.
To enhance the diagnostic and therapeutic aspects of their treatment, we implemented a novel syndromic molecular test in our laboratories. This test is designed to expedite and enhance the management of pneumonia and the stewardship of antibiotics. This research will include 80 to 100 adult patients hospitalized in ICU between Feb 2025 and Feb 2027. It will take place within the Siriraj Hospital, Bangkok, Thailand.
Detailed description
Not provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pneumonia panel group | Experimental | Diagnostic Test: Pneumonia Panel by FilmArrayPneumonia panel measurement and changing of antimicrobials according to the result of pneumonia panel |
| No Intervention: Standard of care | No intervention | –Standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have received complete information about the research and who have not objected to the use of its data
- Patients with suspected pneumonia infection
Key exclusion criteria (6 listed)
- Active immediate life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
- Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage Acute coronary syndrome
- Cardiogenic shock
- Life-threatening gastrointestinal hemorrhage
- Drug overdose
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 |
|---|---|---|
| Pneumonia Panel by FilmArrayThe Pneumonia Panel comprehensively identifies 33 potential pathogen targets from sputum-like (including endotracheal aspirate) and bronchoalveolar lavage (BAL)-like (including mini-BAL) samples. For 15 of the bacteria, the Pneumonia Panel provides semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen. | Diagnostic test | Experimental: Pneumonia panel group |
Primary outcome
Therapeutic decision [Time Frame: 24 hours following the FilmArray results]
Time frame: 24 hours following the FilmArray results
Antibiotic prescription modification following the FilmArray results as: No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Results publication: PubMed 36154180Stafylaki D, Maraki S, Vaporidi K, Georgopoulos D, Kontoyiannis DP, Kofteridis DP, Chamilos G. Impact of Molecular Syndromic Diagnosis of Severe Pneumonia in the Management of Critically Ill Patients. Microbiol Spectr. 2022 Oct 26;10(5):e0161622. doi: 10.1128/spectrum.01616-22. Epub 2022 Sep 26.
- Results publication: PubMed 34620213High J, Enne VI, Barber JA, Brealey D, Turner DA, Horne R, Peters M, Dhesi Z, Wagner AP, Pandolfo AM, Stirling S, Russell C, O'Grady J, Swart AM, Gant V, Livermore DM; INHALE Study Group. INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care-study protocol for a multicentre randomised controlled trial. Trials. 2021 Oct 7;22(1):680. doi: 10.1186/s13063-021-05618-6.
- Results publication: PubMed 35659683Kosai K, Akamatsu N, Ota K, Mitsumoto-Kaseida F, Sakamoto K, Hasegawa H, Izumikawa K, Mukae H, Yanagihara K. BioFire FilmArray Pneumonia Panel enhances detection of pathogens and antimicrobial resistance in lower respiratory tract specimens. Ann Clin Microbiol Antimicrob. 2022 Jun 4;21(1):24. doi: 10.1186/s12941-022-00512-8.
- Individual participant dataSharing planned: No
Related trials for Infectious Disease of Lung
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Recruiting
A Multicenter Randomized Trial of CT-Based AI Decision Support for Early Pneumonia Care
Pneumonia; Pulmonary Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumonia Panel by FilmArray in people with Infectious Disease of Lung and Molecular Diagnosis, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Jan 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adhiratha Boonyasiri, MD, MSc, PhD (+664192688, adhiratha.bon@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic decision [Time Frame: 24 hours following the FilmArray results] (time frame: 24 hours following the FilmArray results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06782607, which also lists 3 linked publications.
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 20 Jan 2025.