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Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections (BALFinder)

Primary Purpose

Lower Respiratory Tract Infections

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bronchoalveolar lavage 120ml
bronchoalveolar lavage 60ml
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Respiratory Tract Infections focused on measuring bronchoalveolar lavage, lower respiratory tract infections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

observation group

Arm Description

Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage

Bronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections
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
Sensitivity and specificity of PCR-based microbiological tests
Microbiological spectrum of pneumonia diagnosed by PCR, as compared with traditional microbiological methods

Full Information

First Posted
June 21, 2016
Last Updated
April 12, 2017
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02852070
Brief Title
Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections
Acronym
BALFinder
Official Title
Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections-A Prospective Multicenter Clinical Trial (BALFinder Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Respiratory Tract Infections
Keywords
bronchoalveolar lavage, lower respiratory tract infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage
Arm Title
observation group
Arm Type
Experimental
Arm Description
Bronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage
Intervention Type
Procedure
Intervention Name(s)
bronchoalveolar lavage 120ml
Intervention Description
120mL sterile saline solution instilled into the distal bronchial tree in 3 times
Intervention Type
Procedure
Intervention Name(s)
bronchoalveolar lavage 60ml
Intervention Description
60mL sterile saline solution instilled into the distal bronchial tree in 3 times
Primary Outcome Measure Information:
Title
Microbiological yield
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections
Time Frame
2 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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
Time Frame
2 years
Title
Sensitivity and specificity of PCR-based microbiological tests
Description
Microbiological spectrum of pneumonia diagnosed by PCR, as compared with traditional microbiological methods
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cao Bin, MD
Phone
86-010-84206264
Email
Caobin_ben@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li lijuan, MD
Phone
86-010-84206264
Email
lilijuan236@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cao Bin, MD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Cao, MD
Phone
86-010-84206264
Email
caobin_ben@163.com
First Name & Middle Initial & Last Name & Degree
Li lijuan, MD
Phone
86-010-84206264
Email
lilijuan236@126.com
First Name & Middle Initial & Last Name & Degree
Bin cao, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections

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