Community-acquired PneumoniaNCT04835818
Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia
A study testing Provide the panel report to the primary care physician in people with Community-acquired Pneumonia and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Critical Illness
- What is being tested?
- Provide the panel report to the primary care physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 May 2019to May 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age >20 y/o)
- ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis
- Treatment with endotracheal Intubation
Who cannot join
- Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)
- Nosocomial infection
Trial locations and contacts
1 site in 1 country.
Yu-Chung Chuang, MD. PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yu-Chung Chuang, MD PhD, 886-2-23123456 ext. 65045, weischuang@gmail.com
Ying-Chun Chien, MD
About this study
Official title: Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia
Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center.
Read the detailed description
Point-of-Care Multiplex PCR Testing could narrow down the pathogens causing severe community-acquired pneumonia(CAP). Our hypothesis is that the result of Point-of-Care Multiplex PCR Testing could help primary physician to reduce antibiotics use.
- Conditions
- Community-acquired Pneumonia, Critical Illness
- Being tested
- Provide the panel report to the primary care physician
- Keywords
- Community-acquired Pneumonia, Critical Illness, Point-of-care
- Medical subject headings
- Community-Acquired Pneumonia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provide the panel report to the primary care physicianDiagnostic test
Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)
| Study group | Role | What they receive |
|---|---|---|
| Reporting | Experimental | check point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician Receives: Diagnostic Test: Provide the panel report to the primary care physician |
| Usual Care | No intervention | check point-of-care Multiplex PCR for pneumonia pathogens but do NOT report results to primary care physician. Let primary care physician provide usual standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous antibiotic-free day within 14 days
days without intravenous antibiotics within 14 days
Measured: up to 14 days
Secondary outcomes (4)
ICU stay
days of stay in ICU
Measured: up to 21 days
Antibiotic-free day within 21 days
days without antibiotics within 21 days
Measured: 21 days
Intravenous antibiotic-free day within 21 days
days without intravenous antibiotics within 21 days
Measured: up to 21 days
Ventilator-free day within 28 days
days without intravenous antibiotics within 28 days
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 May 2019
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chung Chuang, MD. PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835818
- Sponsor's protocol ID
- 201901147RIND
- Status last verified
- Oct 2021
- First submitted
- 5 Apr 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT04835818
- Acronym / sponsor ID
- 201901147RIND
- Conditions
- Community-acquired Pneumonia, Critical Illness
- Keywords
- Community-acquired Pneumonia, Critical Illness, Point-of-care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center.
Detailed description
Point-of-Care Multiplex PCR Testing could narrow down the pathogens causing severe community-acquired pneumonia(CAP). Our hypothesis is that the result of Point-of-Care Multiplex PCR Testing could help primary physician to reduce antibiotics use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reporting | Experimental | Diagnostic Test: Provide the panel report to the primary care physiciancheck point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician |
| Usual Care | No intervention | –check point-of-care Multiplex PCR for pneumonia pathogens but do NOT report results to primary care physician. Let primary care physician provide usual standard care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age >20 y/o)
- ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis
- Treatment with endotracheal Intubation
Key exclusion criteria (2 listed)
- Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)
- Nosocomial infection
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 |
|---|---|---|
| Provide the panel report to the primary care physicianPoint-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray) | Diagnostic test | Reporting |
Primary outcome
Intravenous antibiotic-free day within 14 days
Time frame: up to 14 days
days without intravenous antibiotics within 14 days
4 secondary outcomes
ICU stay
Time frame: up to 21 days
Antibiotic-free day within 21 days
Time frame: 21 days
Intravenous antibiotic-free day within 21 days
Time frame: up to 21 days
Ventilator-free day within 28 days
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Community-acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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.
Yu-Chung Chuang, MD. PhD contact
Yu-Chung Chuang, MD. PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provide the panel report to the primary care physician in people with Community-acquired Pneumonia and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chung Chuang, MD. PhD (886-2-23123456 ext. 65045, weischuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous antibiotic-free day within 14 days (time frame: up to 14 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 13 Oct 2021.