Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure

Department of Critical Care Medicine, Taichung Veterans General Hospital

A prospective observational study. Enrolled participants admitted to ICU due to pneumonia and respiratory failure need mechanical ventilator support. Investigators collected the residual specimens, such as sputum from endotrachea aspiration, bronchoalveolar lavage fluid in those participants as the usual care in the ICU. Those residual samples were sent to extract RNA and sequence by using high-throughput sequencing (next-generation sequencing) method.

Investigators will compared the microbiome feature between lower respiratory tract and stool specimens in those participants diagnosed as pneumonia with respiratory failure.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Pneumonia, Bacterial; Lower Resp Tract Infection; Microbiota
• Intervention / Treatment: Diagnostic test: 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who suffered from pneumonia and respiratory failure needed mechanical ventilator support with inform consent will be enrolled into study

Description

Inclusion Criteria:

• Adults aged than 40 years old
• Diagnosed as pneumonia
• Respiratory failure with mechanical ventilator support

Exclusion Criteria:

• Less than 40 years old
• Has been treated with antibiotics more than 7 days within two weeks before enrolling into study
• Suspected or active pulmonary tuberculosis infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumonia patient with respiratory failure; Sputum and stool sampling day 1, 3 and 7 after enrolling into study	Diagnostic test: 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool; We will check the microbiome in lower respiratory samples (sputum and bronchoalveolar lavage fluid) and stool by using 16S RNA sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dynamics of the airway bacterial microbiome in the lower respiratory tract specimens in the setting of pneumonia accompanied by respiratory failure at the onset of, and day 3 and day 7 (or before extubation)	Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S rRNA sequence of bacteria in residual samples	Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dynamics of the gut bacterial microbiome in the stool specimens in the setting of pneumonia accompanied by respiratory failure at the onset of, and day 3 and day 7 (or before extubation)	uses high-throughput sequencing (next-generation sequencing) to sequence the 16S	Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
The association of the microbiome between lower respiratory tracts and stool specimens in pneumonic patient with respiratory failure	Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S	Compared the association of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pneumonia; Microbiota; Respiratory Failure; Lower Respiratory Tract Infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Insufficiency; Pneumonia; Pneumonia, Bacterial; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: IGA-10601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will share study protocol and Informed Consent Form and Clinical Study Report to other researchers
• IPD Sharing Time Frame: One year after the study was completed
• IPD Sharing Access Criteria: E-mail to yetquen@gmail.com Dr. Pin-Kuei Fu
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No