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CompletedNCT03379779Updated Sep 16, 2019

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

An observational study in Microbiota, Pneumonia, Bacterial and Respiratory Failure, sponsored by Taichung Veterans General Hospital. Completed at 1 site in Taiwan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-09-16.

Sponsored by Taichung Veterans General Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Pneumonia, Bacterial with a site in Taiwan — 2 open to participants now, 2 under way, 1 of them phase 3. Pneumonia, Bacterial · Taiwan.

Started
2017
the only one that year
Observational
3 of 12
1 open now
Registered
6th of 12
by date
Lead sponsor
1 of 12
Taichung Veterans General Hospital

Among the 12 studies in Pneumonia, Bacterial with a site in Taiwan, this one is the only one that started in 2017, is one of 3 observational ones, and was the 6th registered.

Pneumonia, Bacterial

153 studies on the registry are indexed under Pneumonia, Bacterial; 27 are open to participants now.

Browse Pneumonia, Bacterial studies →

Open to participants now

2 of the 12 studies in Pneumonia, Bacterial with a site in Taiwan are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 18 Pneumonia, Bacterial studies recruiting now, 12 (67%) set no upper age limit and 2 (11%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.

This study: 40 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Pneumonia, Bacterial with a site in Taiwan, or all of them as a file.
02

Study 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.

03

Conditions studied

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

Keywords

  • Microbiota
  • Respiratory Failure
  • Pneumonia
  • Lower Respiratory Tract Infection
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged than 40 years old
  • Diagnosed as pneumonia
  • Respiratory failure with mechanical ventilator support

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Pneumonia patient with respiratory failure

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

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

Interventions

  • Diagnostic test16s 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

06

What researchers measure

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)

    Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S rRNA sequence of bacteria in residual samples

    Time frame: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7

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)

    uses high-throughput sequencing (next-generation sequencing) to sequence the 16S

    Time frame: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7

  2. 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

    Time frame: Compared the association of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7

07

Study locations

1 site
  • Taichung Veterans General Hospital
    Taichung, 40705, Taiwan
08

References and documents

Individual participant data

Plan to share: Yes — We will share study protocol and Informed Consent Form and Clinical Study Report to other researchers

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: One year after the study was completed

Access criteria: E-mail to yetquen@gmail.com Dr. Pin-Kuei Fu

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Sep 2019, 24 months.

Of 22 observational studies under Pneumonia, Bacterial, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2017
First posted
Dec 20, 2017
StartActual
Aug 28, 2017
Primary completionActual
Sep 1, 2019
CompletionActual
Sep 1, 2019
Last update
Sep 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03379779
Responsible party
Pin-Kuei Fu, MD, PhD (Principal Investigator, Department of Critical Care Medicine, Taichung Veterans General Hospital) — Principal investigator
First posted
Dec 20, 2017
Start date
Aug 28, 2017
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Sep 16, 2019

Study contacts

Pin-Kuei Fu, MD, PhD
principal investigator · Taichung Veterans General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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