Lower Respiratory Tract InfectionFALRINCT03391076
The Clinical Value of FA in AHLRI Patients
A study testing FilmArray Respiratory Panel in people with Lower Respiratory Tract Infection, run by Bin Cao at 1 site in China.
Trial summary
LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infection
- What is being tested?
- FilmArray Respiratory Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2017to 23 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age >= 18 years old
- Community acquired Pneumonia, acute exacerbation of chronic obstructive pulmonary disease [AECOPD], acute exacerbation of bronchiectasis.
- Hospitalization required
- Informed Consent Form signed
Who cannot join
- Age < 18 years old
- Hospital acquired Pneumonia
- Patients with lung tuberculosis
- Pregnant women
- Patients with immunodeficiency
- Any conditions which may increase PCT levels
- Informed Consent Form not signed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chian Japan Friendship Hospital
Beijing, Beijing Municipality
Shengchen DUAN, doctor, 13488779977, doctordsc@163.com
About this study
Official title: The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study
LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the therapy. In this study, investigators assume that the use of FilmArray Respiratory Panel will provide more rapid and comprehensive evidences to physicians to diagnose LRTI which is caused by viruses or atypical pathogens and then reduce the length of antibiotics use by 0.5-1.0 days as well as other hospital resources (length of hospital/ICU stay, take-away oral antibiotics, etc.). Secondly, investigators assume that in LRTI patients with viral infection and a low serum PCT level, fewer length of antibiotics use can be expected. Thirdly, the use of FilmArray Respiratory Panel will provide clearer epidemiology data of virus and atypical pathogens in hospitalized LRTI patients.
- Conditions
- Lower Respiratory Tract Infection
- Being tested
- FilmArray Respiratory Panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray Respiratory PanelDiagnostic test
An Multi-PCR method which can detect 20 pathogens in 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| FilmArray group | Experimental | Patients in this group will use FilmArray Respiratory Panel to test potential viral pathogens. Receives: Diagnostic Test: FilmArray Respiratory Panel |
| Routine test group | No intervention | Patients in this group will use clinical routine methods to test potential viral pathogens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length (days) of antibiotics therapy in hospital between two groups.
The duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered.
Measured: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary outcomes (4)
Antibiotics therapy cost
Measured: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Length of hospital stay (LOS) and/or ICU stay
Measured: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
The correlation between the initial serum PCT level and clinical outcomes/mortality
Measured: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients
Measured: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start21 Sep 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion23 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Cao
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor-investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391076
- Sponsor's protocol ID
- 20170909
- Acronym
- FALRI
- Status last verified
- Oct 2018
- First submitted
- 7 Dec 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Shengchen D, Gu X, Fan G, Sun R, Wang Y, Yu D, Li H, Zhou F, Xiong Z, Lu B, Zhu G, Cao B. Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial. Clin Microbiol Infect. 2019 Nov;25(11):1415-1421. doi: 10.1016/j.cmi.2019.06.012. Epub 2019 Jun 20.
PubMed 31229593
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03391076
- Acronym / sponsor ID
- FALRI / 20170909
- Conditions
- Lower Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Bin CaoUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 23 Oct 2018 (estimated)
- First posted
- 5 Jan 2018 (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.
LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the therapy. In this study, investigators assume that the use of FilmArray Respiratory Panel will provide more rapid and comprehensive evidences to physicians to diagnose LRTI which is caused by viruses or atypical pathogens and then reduce the length of antibiotics use by 0.5-1.0 days as well as other hospital resources (length of hospital/ICU stay, take-away oral antibiotics, etc.). Secondly, investigators assume that in LRTI patients with viral infection and a low serum PCT level, fewer length of antibiotics use can be expected. Thirdly, the use of FilmArray Respiratory Panel will provide clearer epidemiology data of virus and atypical pathogens in hospitalized LRTI patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FilmArray group | Experimental | Diagnostic Test: FilmArray Respiratory PanelPatients in this group will use FilmArray Respiratory Panel to test potential viral pathogens. |
| Routine test group | No intervention | –Patients in this group will use clinical routine methods to test potential viral pathogens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age >= 18 years old
- Community acquired Pneumonia, acute exacerbation of chronic obstructive pulmonary disease [AECOPD], acute exacerbation of bronchiectasis.
- Hospitalization required
- Informed Consent Form signed
Key exclusion criteria (7 listed)
- Age < 18 years old
- Hospital acquired Pneumonia
- Patients with lung tuberculosis
- Pregnant women
- Patients with immunodeficiency
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 |
|---|---|---|
| FilmArray Respiratory PanelAn Multi-PCR method which can detect 20 pathogens in 45 minutes. | Diagnostic test | FilmArray group |
Primary outcome
The length (days) of antibiotics therapy in hospital between two groups.
Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
The duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered.
4 secondary outcomes
Antibiotics therapy cost
Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Length of hospital stay (LOS) and/or ICU stay
Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
The correlation between the initial serum PCT level and clinical outcomes/mortality
Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients
Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 31229593Shengchen D, Gu X, Fan G, Sun R, Wang Y, Yu D, Li H, Zhou F, Xiong Z, Lu B, Zhu G, Cao B. Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial. Clin Microbiol Infect. 2019 Nov;25(11):1415-1421. doi: 10.1016/j.cmi.2019.06.012. Epub 2019 Jun 20.
- Individual participant dataSharing planned: Undecided
Related trials for Lower Respiratory Tract Infection
RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FilmArray Respiratory Panel in people with Lower Respiratory Tract Infection, run by Bin Cao at 1 site in China.
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 4 inclusion and 7 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 9 Oct 2018. 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 China. 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 Shengchen DUAN, doctor (13488779977, doctordsc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length (days) of antibiotics therapy in hospital between two groups. (time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months). 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 NCT03391076, which also lists 1 linked publication.
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 9 Oct 2018.