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

Completed

• Conditions: Pneumonia, Bacterial; Respiratory Failure; Microbiota; Lower Resp Tract Infection
• Interventions: Diagnostic Test: 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool

• Registration Number: NCT03379779
• Lead Sponsor: Taichung Veterans General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-28
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-20
• Status Verified: 2019-09
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pneumonia patient with respiratory failure	16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool	Sputum and stool sampling day 1, 3 and 7 after enrolling into study

Primary Outcome Measures

Name	Time	Method
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)	Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7	Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S rRNA sequence of bacteria in residual samples

Secondary Outcome Measures

Name	Time	Method
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	uses high-throughput sequencing (next-generation sequencing) to sequence the 16S
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	Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan