- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852070
Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections (BALFinder)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cao Bin, MD
- Phone Number: 86-010-84206264
- Email: Caobin_ben@163.com
Study Contact Backup
- Name: Li lijuan, MD
- Phone Number: 86-010-84206264
- Email: lilijuan236@126.com
Study Locations
-
-
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Beijing, China, 100029
- Recruiting
- China-Japan Friendship Hospital
-
Contact:
- Li lijuan, MD
- Phone Number: 86-010-84206264
- Email: lilijuan236@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of lower respiratory infection
- Indication for bronchoalveolar lavage.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: control group
Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage
|
120mL sterile saline solution instilled into the distal bronchial tree in 3 times
|
EXPERIMENTAL: observation group
Bronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage
|
60mL sterile saline solution instilled into the distal bronchial tree in 3 times
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections
Time Frame: 2 years
|
2 years
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 2 years
|
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
|
2 years
|
Sensitivity and specificity of PCR-based microbiological tests
Time Frame: 2 years
|
Microbiological spectrum of pneumonia diagnosed by PCR, as compared with traditional microbiological methods
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Cao Bin, MD, China-Japan Friendship Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCT02852070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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