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

Respiratory Failure Clinical Trial

Official title:

Department of Critical Care Medicine, Taichung Veterans General Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379779
• Other study ID #: IGA-10601
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Resp Tract Infection
• Microbiota
• Pneumonia
• Pneumonia, Bacterial
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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