Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections (BALFinder)
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|ClinicalTrials.gov Identifier: NCT02852070|
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : April 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lower Respiratory Tract Infections||Procedure: bronchoalveolar lavage 120ml Procedure: bronchoalveolar lavage 60ml||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections-A Prospective Multicenter Clinical Trial (BALFinder Study)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||July 2018|
Active Comparator: control group
Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage
Procedure: bronchoalveolar lavage 120ml
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
Procedure: bronchoalveolar lavage 60ml
60mL sterile saline solution instilled into the distal bronchial tree in 3 times
- 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
- 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 ]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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852070
|Contact: Cao Bin, MD||86-010-84206264||Caobin_ben@163.com|
|Contact: Li lijuan, MDemail@example.com|
|China-Japan Friendship Hospital||Recruiting|
|Beijing, China, 100029|
|Contact: Bin Cao, MD 86-010-84206264 firstname.lastname@example.org|
|Contact: Li lijuan, MD 86-010-84206264 email@example.com|
|Principal Investigator: Bin cao, MD|
|Study Chair:||Cao Bin, MD||China-Japan Friendship Hospital|