Skip to main content
OpenTrials
Completed

NCT Number: NCT03379779

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Microbiota Bacterial Infections Bacterial Infections and Mycoses Infections Lower Resp Tract Infection Lung Diseases Pneumonia Pneumonia, Bacterial Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

    Time frame: 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 outcomes

  1. 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)

    Time frame: 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

  2. The association of the microbiome between lower respiratory tracts and stool specimens in pneumonic patient with respiratory failure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Department of Critical Care Medicine, Taichung Veterans General Hospital

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.