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

Lower Respiratory Tract Infections Clinical Trial

— BALFinder  

Official title:

Study Bronchoalveolar Lavage Fluid Driven Pathogenic Diagnosis of Lower Respiratory Tract Infections-A Prospective Multicenter Clinical Trial (BALFinder Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02852070
• Other study ID #: NCT02852070
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2016
• Last updated: April 12, 2017
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: Capital Medical University
• Contact: Cao Bin, MD
• Phone: 86-010-84206264
• Email: Caobin_ben[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lower Respiratory Tract Infections
• Respiratory Tract Infections

Intervention

Procedure:
• bronchoalveolar lavage 120ml
120mL sterile saline solution instilled into the distal bronchial tree in 3 times
• bronchoalveolar lavage 60ml
60mL sterile saline solution instilled into the distal bronchial tree in 3 times

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	Sensitivity and specificity of BALF galactomannan test in the diagnosis of invasive pulmonary fungal infections		2 years
Secondary	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	2 years
Secondary	Sensitivity and specificity of PCR-based microbiological tests	Microbiological spectrum of pneumonia diagnosed by PCR, as compared with traditional microbiological methods	2 years