Clinical trial NCT03379779: Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure
Official title: Department of Critical Care Medicine, Taichung Veterans General Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbiota
Pneumonia, Bacterial
Respiratory Failure
Lower Resp Tract Infection
Keywords: Microbiota
Respiratory Failure
Pneumonia
Lower Respiratory Tract Infection
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
Secondary outcomes:
measure: 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)
timeFrame: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
measure: The association of the microbiome between lower respiratory tracts and stool specimens in pneumonic patient with respiratory failure
timeFrame: Compared the association of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Pin-Kuei Fu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: