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

NCT02852070 | Unknown

• 1 other identifier: NCT02852070
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Respiratory Tract Infections

Keywords

bronchoalveolar lavage; lower respiratory tract infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  2 years

• Sensitivity and specificity of PCR-based microbiological tests

  2 years

Study Arms (2)

control group

ACTIVE COMPARATOR

Bronchoscopy examination with 120ml sterile saline solution for bronchoalveolar lavage

Procedure: bronchoalveolar lavage 120ml

observation group

EXPERIMENTAL

Bronchoscopy examination with 60ml sterile saline solution for bronchoalveolar lavage

Procedure: bronchoalveolar lavage 60ml

Interventions

bronchoalveolar lavage 120ml PROCEDURE

120mL sterile saline solution instilled into the distal bronchial tree in 3 times

control group

bronchoalveolar lavage 60ml PROCEDURE

60mL sterile saline solution instilled into the distal bronchial tree in 3 times

observation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of lower respiratory infection
• Indication for bronchoalveolar lavage.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

MeSH Terms

Interventions

Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Cao Bin, MD

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Cao Bin, MD

CONTACT

86-010-84206264; Caobin_ben@163.com

Li lijuan, MD

CONTACT

86-010-84206264; lilijuan236@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)