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: Unknown
• Conditions: Lower Respiratory Tract Infections
• Intervention / Treatment: Procedure: bronchoalveolar lavage 120ml; Procedure: bronchoalveolar lavage 60ml

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: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • 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: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Cao Bin, MD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (ESTIMATE): August 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: bronchoalveolar lavage; lower respiratory tract infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: NCT02852070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO