PneumoniaPhase 2IRISPAT-1NCT06478953
Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy
A Phase 2 study testing FA Pneumonia Panel in people with Pneumonia and Critically Ill, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this intervention trial is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in mechanically ventilated critically ill patients with suspected pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Critically Ill
- What is being tested?
- FA Pneumonia Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Jun 2024to 1 Nov 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (≥18 years old) ICU patients
- mechanical ventilation
- new antibiotic prescription within 24 hours for suspected community acquired, healthcare or ventilator associated pneumonia
- suspected pneumonia is defined as any of purulent sputum, cough, fever, shortness of breath, hypoxia, hypercapnia or abnormal white cell count AND chest infiltrates on imaging
- need for antibiotics other than suspected respiratory infection
- aspiration pneumonia
Show all 16Show fewer
- suspected pneumonia due to tuberculosis
- known respiratory pathogens within 7 days prior to randomization
- given empirical antimicrobials for suspected Stenotrophomonas infection
- lack of sufficient respiratory samples for culture and FA Pneumonia Panel
- not expected to survive beyond 48 hours
- limitation of therapy prior to recruitment
- prisoners
- allergy to antibiotics
- immunosuppression from long term steroid of at least 5 mg/day or chemotherapy or HIV or haematological disease
- pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy: a Pilot, Randomized, Controlled Open-label Feasibility Trial (IRISPAT-1)
The goal of this intervention trial is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in mechanically ventilated critically ill patients with suspected pneumonia.
Participants will randomized to either have an urgent BioFire FA Pneumonia Panel assay performed or recieve standard of care to guide antimicrobial therapy and treatment of pneumonia.
Read the detailed description
Pneumonia is the most common cause of sepsis requiring admission to the intensive care unit (ICU). Molecular pathogen detection techniques such as polymerase chain reaction (PCR) may help optimize antimicrobial therapy. Its utility for diagnosing respiratory viral infections such as influenza is well established, and was an essential diagnostic tool during the coronavirus 2019 (COVID-19) pandemic. However, its use remains limited for bacterial pathogens. The rationale to use PCR based bacterial detection to facilitate antibiotic stewardship is threefold. First, it may shorten the time to pathogen detection. Second, it has improved sensitivity over conventional culture techniques, particularly for pathogens that are difficult to culture. Third, it can detect resistant genes to inform antimicrobial sensitivity. Taken together, utilization of bacterial PCR may shorten time to appropriate antimicrobial therapy and minimize injudicious use of broad-spectrum antimicrobials in patients who do not have infection from MDRO.
The BioFire® FilmArray® Pneumonia Panel (FA Pneumonia Panel) is a PCR based in vitro assay which rapidly identifies 8 viral and 18 bacterial common pathogens in tracheal aspirate and bronchoalveolar lavage (BAL) samples. Clinical studies showed that FA Pneumonia Panel on BAL specimens have sensitivity of 75 to 100% and specificity of >91% for the pathogens tested. Retrospective analysis suggests utilizing FA Pneumonia Panel may facilitate discontinuation or de-escalation of antimicrobials in 48% of patients with an average reduction of 6 antibiotic days. However, currently there are no randomized controlled trials that assessed the efficacy of FA Pneumonia Panel on improving antimicrobial stewardship.
Addition of FA Pneumonia Panel to standard care should shorten time to pathogen and resistance detection, enhance sensitivity over conventional microbiological cultures and shorten time to appropriate antimicrobial therapy by reducing over-narrow and over-broad coverage. Robust clinical trials are now needed to test these hypotheses. We propose to conduct a pilot, randomized, controlled open-label trial designed to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia.
The goal is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by BioFire FilmArray Pneumonia Panel on antimicrobial therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia.
- Conditions
- Pneumonia, Critically Ill
- Being tested
- FA Pneumonia Panel
- Keywords
- infection, antimicrobial, antibiotics, multidrug resistant organisms, antibiotic stewardship, intensive care
- Medical subject headings
- Pneumonia, Critical Illness, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FA Pneumonia PanelDiagnostic test
A single BioFire® FilmArray® Pneumonia Panel assay will be performed on a respiratory clinical specimen.
| Study group | Role | What they receive |
|---|---|---|
| FA Pneumonia Panel Guided Group | Experimental | Patients in the FA Pneumonia Panel guided group will have a BioFire® FilmArray® Pneumonia Panel assay performed as soon as possible but within 24 hours of new antibiotic prescription for suspected respiratory infection in addition to all the investigations performed in standard care. Based on the rapid test results, antimicrobial therapy will be adjusted according to a pre-determined treatment algorithm and antimicrobial guidelines. The treatment algorithm and antimicrobial guidelines were based on the latest hospital antibiogram, procalcitonin protocol, and consensus recommendations from microbiologists, infectious disease experts and intensive care physicians at our hospital. The treating clinical team will also be given the standard microbiological culture with sensitivity results when available. The treating clinical team may override the pre-determined antimicrobial algorithm for any clinical reason at any time and the rationale will be recorded. Receives: Diagnostic Test: FA Pneumonia Panel |
| Standard Care Group | No intervention | Patients in the standard care group will receive antimicrobial therapy guided by conventional microbiological cultures and standardized procalcitonin protocol. Choice of antimicrobial agent is based on use of the narrowest-spectrum antimicrobial agent possible according to culture sensitivity. Current standard investigations for any patient mechanically ventilated for suspected pneumonia in our ICU includes two sets of blood cultures, alternative day procalcitonin, respiratory specimen of tracheal aspirate or bronchoalveolar lavage for bacterial gram stain and cultures, respiratory viral PCR and urine streptococcus and legionella antigen. FA Pneumonia Panel will be performed from concurrent respiratory samples in the standard care group at the end of the study and the results will not be used by the treating clinical team for treatment decisions. Blinded results will only be available to the antimicrobial review panel for outcome assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval to appropriate antimicrobial therapy
Defined as the time interval (hours) from time of randomization to earliest time that appropriate antimicrobial therapy is achieved as determined by the antimicrobial stewardship review panel.
Measured: 7 days
Secondary outcomes (9)
Proportion of patients with appropriate antimicrobial therapy at 48 hours after randomization
Defined as the proportion of patients with appropriate antimicrobial therapy at 48 hours after randomization as determined by the antimicrobial stewardship review panel
Measured: 48 hours
Time interval to pathogen detection
Defined as the time interval (hours) between culture or FA Pneumonia Panel sampling time to reporting time that confirmed the presence (with sensitivity pattern) or absence any causative pathogens from the tracheal aspirate or BAL sample taken after randomization.
Measured: 7 days
Duration of antimicrobial therapy between FA Pneumonia Panel guided and standard care group
Defined as the duration (hours) of antimicrobial therapy given after randomization until hospital discharge
Measured: 28 days
Proportion of patients on broad-spectrum antibiotics at 48 hours after randomization
Defined as the proportion of patients who are prescribed carbapenem, tigecycline, ceftolozane-tazobactam, ceftaroline, ceftazidime/avibactam, linezolid, vancomycin, daptomycin, aztreonam or cefiderocol at 48 hours after randomization.
Measured: 48 hours
Ventilator free days
Defined as the number of days free from mechanical ventilation 28 days after randomization.
Measured: 28 days
Vasopressor free days
Defined as the number of days free from vasopressor therapy 28 days after randomization.
Measured: 28 days
ICU length of stay
Defined as the duration (days) of ICU length of stay
Measured: 28 days
28-day mortality
Defined as the all-cause mortality rate on or before 28 days after randomization
Measured: 28 days
Proportion of patients who require re-initiation or escalation of antimicrobial therapy after 48 hours of discontinuation or de-escalation
Defined as the proportion of patients who required restart or escalation of antimicrobial therapy after discontinuation or de-escalation after ≥ 48 hours
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start26 Jun 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
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 Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, randomized, controlled open-label trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lowell Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478953
- Sponsor's protocol ID
- 2023.327
- Acronym
- IRISPAT-1
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy: a Pilot, Randomized, Controlled Open-label Feasibility Trial (IRISPAT-1)
- ClinicalTrials.gov ID
- NCT06478953
- Acronym / sponsor ID
- IRISPAT-1 / 2023.327
- Conditions
- Pneumonia, Critically Ill
- Keywords
- infection, antimicrobial, antibiotics, multidrug resistant organisms, antibiotic stewardship, intensive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 27 Jun 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.
The goal of this intervention trial is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in mechanically ventilated critically ill patients with suspected pneumonia.
Participants will randomized to either have an urgent BioFire FA Pneumonia Panel assay performed or recieve standard of care to guide antimicrobial therapy and treatment of pneumonia.
Detailed description
Pneumonia is the most common cause of sepsis requiring admission to the intensive care unit (ICU). Molecular pathogen detection techniques such as polymerase chain reaction (PCR) may help optimize antimicrobial therapy. Its utility for diagnosing respiratory viral infections such as influenza is well established, and was an essential diagnostic tool during the coronavirus 2019 (COVID-19) pandemic. However, its use remains limited for bacterial pathogens. The rationale to use PCR based bacterial detection to facilitate antibiotic stewardship is threefold. First, it may shorten the time to pathogen detection. Second, it has improved sensitivity over conventional culture techniques, particularly for pathogens that are difficult to culture. Third, it can detect resistant genes to inform antimicrobial sensitivity. Taken together, utilization of bacterial PCR may shorten time to appropriate antimicrobial therapy and minimize injudicious use of broad-spectrum antimicrobials in patients who do not have infection from MDRO.
The BioFire® FilmArray® Pneumonia Panel (FA Pneumonia Panel) is a PCR based in vitro assay which rapidly identifies 8 viral and 18 bacterial common pathogens in tracheal aspirate and bronchoalveolar lavage (BAL) samples. Clinical studies showed that FA Pneumonia Panel on BAL specimens have sensitivity of 75 to 100% and specificity of >91% for the pathogens tested. Retrospective analysis suggests utilizing FA Pneumonia Panel may facilitate discontinuation or de-escalation of antimicrobials in 48% of patients with an average reduction of 6 antibiotic days. However, currently there are no randomized controlled trials that assessed the efficacy of FA Pneumonia Panel on improving antimicrobial stewardship.
Addition of FA Pneumonia Panel to standard care should shorten time to pathogen and resistance detection, enhance sensitivity over conventional microbiological cultures and shorten time to appropriate antimicrobial therapy by reducing over-narrow and over-broad coverage. Robust clinical trials are now needed to test these hypotheses. We propose to conduct a pilot, randomized, controlled open-label trial designed to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia.
The goal is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by BioFire FilmArray Pneumonia Panel on antimicrobial therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot, randomized, controlled open-label trial
| Arm | Type | Receives |
|---|---|---|
| FA Pneumonia Panel Guided Group | Experimental | Diagnostic Test: FA Pneumonia PanelPatients in the FA Pneumonia Panel guided group will have a BioFire® FilmArray® Pneumonia Panel assay performed as soon as possible but within 24 hours of new antibiotic prescription for suspected respiratory infection in addition to all the investigations performed in standard care. Based on the rapid test results, antimicrobial therapy will be adjusted according to a pre-determined treatment algorithm and antimicrobial guidelines. The treatment algorithm and antimicrobial guidelines were based on the latest hospital antibiogram, procalcitonin protocol, and consensus recommendations from microbiologists, infectious disease experts and intensive care physicians at our hospital. The treating clinical team will also be given the standard microbiological culture with sensitivity results when available. The treating clinical team may override the pre-determined antimicrobial algorithm for any clinical reason at any time and the rationale will be recorded. |
| Standard Care Group | No intervention | –Patients in the standard care group will receive antimicrobial therapy guided by conventional microbiological cultures and standardized procalcitonin protocol. Choice of antimicrobial agent is based on use of the narrowest-spectrum antimicrobial agent possible according to culture sensitivity. Current standard investigations for any patient mechanically ventilated for suspected pneumonia in our ICU includes two sets of blood cultures, alternative day procalcitonin, respiratory specimen of tracheal aspirate or bronchoalveolar lavage for bacterial gram stain and cultures, respiratory viral PCR and urine streptococcus and legionella antigen. FA Pneumonia Panel will be performed from concurrent respiratory samples in the standard care group at the end of the study and the results will not be used by the treating clinical team for treatment decisions. Blinded results will only be available to the antimicrobial review panel for outcome assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- adult (≥18 years old) ICU patients
- mechanical ventilation
- new antibiotic prescription within 24 hours for suspected community acquired, healthcare or ventilator associated pneumonia
- suspected pneumonia is defined as any of purulent sputum, cough, fever, shortness of breath, hypoxia, hypercapnia or abnormal white cell count AND chest infiltrates on imaging
- need for antibiotics other than suspected respiratory infection
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FA Pneumonia PanelA single BioFire® FilmArray® Pneumonia Panel assay will be performed on a respiratory clinical specimen. | Diagnostic test | FA Pneumonia Panel Guided Group |
Primary outcome
Time interval to appropriate antimicrobial therapy
Time frame: 7 days
Defined as the time interval (hours) from time of randomization to earliest time that appropriate antimicrobial therapy is achieved as determined by the antimicrobial stewardship review panel.
9 secondary outcomes
Proportion of patients with appropriate antimicrobial therapy at 48 hours after randomization
Time frame: 48 hours
Time interval to pathogen detection
Time frame: 7 days
Duration of antimicrobial therapy between FA Pneumonia Panel guided and standard care group
Time frame: 28 days
Proportion of patients on broad-spectrum antibiotics at 48 hours after randomization
Time frame: 48 hours
Ventilator free days
Time frame: 28 days
Vasopressor free days
Time frame: 28 days
ICU length of stay
Time frame: 28 days
28-day mortality
Time frame: 28 days
Proportion of patients who require re-initiation or escalation of antimicrobial therapy after 48 hours of discontinuation or de-escalation
Time frame: 7 days
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 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing FA Pneumonia Panel in people with Pneumonia and Critically Ill, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 16 inclusion and 0 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 6 Mar 2026. 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 Hong Kong. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time interval to appropriate antimicrobial therapy (time frame: 7 days). 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 6 Mar 2026.