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

NCT ID: NCT03379779

Last Updated: 2019-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-28

Study Completion Date

2019-09-01

Brief Summary

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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

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Conditions

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Microbiota Pneumonia, Bacterial Respiratory Failure Lower Resp Tract Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pneumonia patient with respiratory failure

Sputum and stool sampling day 1, 3 and 7 after enrolling into study

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pin-Kuei Fu, MD, PhD

Principal Investigator, Department of Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pin-Kuei Fu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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IGA-10601

Identifier Type: -

Identifier Source: org_study_id

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