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

NCT03379779 | Completed

• 1 other identifier: IGA-10601
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbiota; Pneumonia, Bacterial; Respiratory Failure; Lower Resp Tract Infection

Keywords

Microbiota; Respiratory Failure; Pneumonia; Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

  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

  Compared the association of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7

Study Arms (1)

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

Interventions

16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool DIAGNOSTIC_TEST

We will check the microbiome in lower respiratory samples (sputum and bronchoalveolar lavage fluid) and stool by using 16S RNA sequencing

Pneumonia patient with respiratory failure

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample obtained for cytokines detection

MeSH Terms

Conditions

Pneumonia, Bacterial; Respiratory Insufficiency; Pneumonia

Interventions

Defecation

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Pin-Kuei Fu, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Critical Care Medicine

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: August 28, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: One year after the study was completed
• Access Criteria: E-mail to yetquen@gmail.com Dr. Pin-Kuei Fu

Locations

TW (1)