Lower Respiratory Tract InfectionsBALFinderNCT02852070
Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections
A study testing bronchoalveolar lavage 120ml and bronchoalveolar lavage 60ml in people with Lower Respiratory Tract Infections, run by Capital Medical University at 1 site in China.
Trial summary
Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of lower respiratory tract infection. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract Infections
- What is being tested?
- bronchoalveolar lavage 120ml and bronchoalveolar lavage 60ml
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of lower respiratory infection
- Indication for bronchoalveolar lavage.
Who cannot join
- Noninfectious pulmonary infiltration
- Contraindication of bronchoscopy： Severe heart or pulmonary dysfunction Recent occurrence of myocardial infarction unstable angina pectoris Severe coagulation disorders (DIC), Massive hemoptysis Gastrointestinal bleeding Thrombocytopenia (<50*109/L) Severe superior vena cava obstruction syndrome Aortic aneurysm Multiple pulmonary bulla Extreme exhaustion
- Diagnosed or highly suspected of tuberculosis infection
- Researchers think that can not be entered into the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Bin Cao, MD, 86-010-84206264, caobin_ben@163.com
Li lijuan, MD, 86-010-84206264, lilijuan236@126.com
About this study
Official title: Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections-A Prospective Multicenter Clinical Trial (BALFinder Study)
Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of lower respiratory tract infection.
Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml), including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and other bronchoalveolar lavage related adverse events.
Read the detailed description
The morbidity and mortality of lower respiratory tract infection gradually increased in recent years, but the etiological diagnosis rate is still low. Quickly identifying the pathogenic bacteria and the corresponding antimicrobial therapy treatment is particularly important. Fibrotic bronchoscopy combined with bronchoalveolar lavage (BAL) has become a routine diagnostic tool for pulmonary infections in immunocompromised patients.
The correct operation of bronchoalveolar lavage and normalization of bronchoalveolar lavage fluid is a prerequisite for the exact results of the pathogen of BALF.
American Thoracic Society recommended amount of 100-300ml of saline solution was instilled into the distal bronchial tree in the diagnosis of interstitial lung diseases. But there is no standard of lavage fluid volume in the etiological diagnosis of lower respiratory tract infections, ranging from 60ml to 250ml ever reported in literature.
Less lavage volume would be more safer in patients with lower respiratory tract infections. The investigators hypothesize that microbiological yield would be no significant difference in patients with low volume （60ml) compared with large volume (120ml).
The purpose of this study is to explore a more effective and safer way of bronchoalveolar lavage in lower respiratory tract infection patients, and determine the pathogenic distribution among them.
- Conditions
- Lower Respiratory Tract Infections
- Being tested
- bronchoalveolar lavage 120ml, bronchoalveolar lavage 60ml
- Keywords
- bronchoalveolar lavage, lower respiratory tract infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoalveolar lavage 120mlProcedure or surgery
120mL sterile saline solution instilled into the distal bronchial tree in 3 times
bronchoalveolar lavage 60mlProcedure or surgery
60mL sterile saline solution instilled into the distal bronchial tree in 3 times
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage Receives: Procedure: bronchoalveolar lavage 120ml |
| observation group | Experimental | Bronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage Receives: Procedure: bronchoalveolar lavage 60ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological yield
Comparison of microbiological yield of two arms with different BALF volume in patients with lower respiratory tract infection in a multicenter, prospective, randomized, single blind study
Measured: 2 years
Secondary outcomes (3)
Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections
Measured: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Compare the safety of two groups included incidence of hospital acquired penumonia within 14 days after bronchoscopy, and vital signs, oxygenation, and laboratory tests before and after lavage
Measured: 2 years
Sensitivity and specificity of PCR-based microbiological tests
Microbiological spectrum of pneumonia diagnosed by PCR, as compared with traditional microbiological methods
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Cao Bin, MD, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852070
- Sponsor's protocol ID
- NCT02852070
- Acronym
- BALFinder
- Status last verified
- Apr 2017
- First submitted
- 21 Jun 2016
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections-A Prospective Multicenter Clinical Trial (BALFinder Study)
- ClinicalTrials.gov ID
- NCT02852070
- Acronym / sponsor ID
- BALFinder / NCT02852070
- Conditions
- Lower Respiratory Tract Infections
- Keywords
- bronchoalveolar lavage, lower respiratory tract infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- 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.
Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of lower respiratory tract infection.
Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml), including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and other bronchoalveolar lavage related adverse events.
Detailed description
The morbidity and mortality of lower respiratory tract infection gradually increased in recent years, but the etiological diagnosis rate is still low. Quickly identifying the pathogenic bacteria and the corresponding antimicrobial therapy treatment is particularly important. Fibrotic bronchoscopy combined with bronchoalveolar lavage (BAL) has become a routine diagnostic tool for pulmonary infections in immunocompromised patients.
The correct operation of bronchoalveolar lavage and normalization of bronchoalveolar lavage fluid is a prerequisite for the exact results of the pathogen of BALF.
American Thoracic Society recommended amount of 100-300ml of saline solution was instilled into the distal bronchial tree in the diagnosis of interstitial lung diseases. But there is no standard of lavage fluid volume in the etiological diagnosis of lower respiratory tract infections, ranging from 60ml to 250ml ever reported in literature.
Less lavage volume would be more safer in patients with lower respiratory tract infections. The investigators hypothesize that microbiological yield would be no significant difference in patients with low volume （60ml) compared with large volume (120ml).
The purpose of this study is to explore a more effective and safer way of bronchoalveolar lavage in lower respiratory tract infection patients, and determine the pathogenic distribution among them.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: bronchoalveolar lavage 120mlBronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage |
| observation group | Experimental | Procedure: bronchoalveolar lavage 60mlBronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of lower respiratory infection
- Indication for bronchoalveolar lavage.
Key exclusion criteria (4 listed)
- Noninfectious pulmonary infiltration
- Contraindication of bronchoscopy： Severe heart or pulmonary dysfunction Recent occurrence of myocardial infarction unstable angina pectoris Severe coagulation disorders (DIC), Massive hemoptysis Gastrointestinal bleeding Thrombocytopenia (<50*109/L) Severe superior vena cava obstruction syndrome Aortic aneurysm Multiple pulmonary bulla Extreme exhaustion
- Diagnosed or highly suspected of tuberculosis infection
- Researchers think that can not be entered into the group.
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 |
|---|---|---|
| bronchoalveolar lavage 120ml120mL sterile saline solution instilled into the distal bronchial tree in 3 times | Procedure or surgery | control group |
| bronchoalveolar lavage 60ml60mL sterile saline solution instilled into the distal bronchial tree in 3 times | Procedure or surgery | observation group |
Primary outcome
Microbiological yield
Time frame: 2 years
Comparison of microbiological yield of two arms with different BALF volume in patients with lower respiratory tract infection in a multicenter, prospective, randomized, single blind study
3 secondary outcomes
Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections
Time frame: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Sensitivity and specificity of PCR-based microbiological tests
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Cao Bin, MD study chair
China-Japan Friendship 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 bronchoalveolar lavage 120ml and bronchoalveolar lavage 60ml in people with Lower Respiratory Tract Infections, run by Capital Medical University 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 2 inclusion and 4 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 14 Apr 2017. 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 Cao Bin, MD (86-010-84206264, Caobin_ben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological yield (time frame: 2 years). 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 14 Apr 2017.