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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
Sponsor:
Information provided by (Responsible Party):
Bin Cao, Capital Medical University

Brief 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections [ Time Frame: 2 years ]
  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of lower respiratory infection
  2. Indication for bronchoalveolar lavage.

Exclusion Criteria:

  1. Noninfectious pulmonary infiltration
  2. 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
  3. Diagnosed or highly suspected of tuberculosis infection
  4. Researchers think that can not be entered into the group.

Information from the National Library of Medicine

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


Contacts
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Contact: Cao Bin, MD 86-010-84206264 Caobin_ben@163.com
Contact: Li lijuan, MD 86-010-84206264 lilijuan236@126.com

Locations
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China
China-Japan Friendship Hospital Recruiting
Beijing, China, 100029
Contact: Bin Cao, MD    86-010-84206264    caobin_ben@163.com   
Contact: Li lijuan, MD    86-010-84206264    lilijuan236@126.com   
Principal Investigator: Bin cao, MD         
Sponsors and Collaborators
Capital Medical University
Investigators
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Study Chair: Cao Bin, MD China-Japan Friendship Hospital

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Responsible Party: Bin Cao, Clinical professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02852070     History of Changes
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bin Cao, Capital Medical University:
bronchoalveolar lavage
lower respiratory tract infections

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pharmaceutical Solutions