MicrobiotaNCT03379779
Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure
An observational study of Microbiota and Pneumonia, Bacterial, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Microbiota, Pneumonia, Bacterial, Respiratory Failure
- What is being tested?
- 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Aug 2017to 1 Sep 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who suffered from pneumonia and respiratory failure needed mechanical ventilator support with inform consent will be enrolled into study
Who may be able to join
- Adults aged than 40 years old
- Diagnosed as pneumonia
- Respiratory failure with mechanical ventilator support
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Critical Care Medicine, Taichung Veterans General Hospital
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.
- Being tested
- 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool
- Keywords
- Microbiota, Respiratory Failure, Pneumonia, Lower Respiratory Tract Infection
- Medical subject headings
- Pneumonia, Bacterial, Respiratory Insufficiency, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stoolDiagnostic test
We will check the microbiome in lower respiratory samples (sputum and bronchoalveolar lavage fluid) and stool by using 16S RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia patient with respiratory failure | Sputum and stool sampling day 1, 3 and 7 after enrolling into study Receives: Diagnostic Test: 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
Secondary outcomes (2)
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
Measured: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
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
Measured: Compared the association of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start28 Aug 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital
- Investigators
- Pin-Kuei Fu, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379779
- Sponsor's protocol ID
- IGA-10601
- Status last verified
- Sep 2019
- First submitted
- 14 Dec 2017
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share study protocol and Informed Consent Form and Clinical Study Report to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Critical Care Medicine, Taichung Veterans General Hospital
- ClinicalTrials.gov ID
- NCT03379779
- Acronym / sponsor ID
- IGA-10601
- Keywords
- Microbiota, Respiratory Failure, Pneumonia, Lower Respiratory Tract Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumonia patient with respiratory failure | – | Diagnostic Test: 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stoolSputum and stool sampling day 1, 3 and 7 after enrolling into study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who suffered from pneumonia and respiratory failure needed mechanical ventilator support with inform consent will be enrolled into study
Key inclusion criteria (3 listed)
- Adults aged than 40 years old
- Diagnosed as pneumonia
- Respiratory failure with mechanical ventilator support
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stoolWe will check the microbiome in lower respiratory samples (sputum and bronchoalveolar lavage fluid) and stool by using 16S RNA sequencing | Diagnostic test | Pneumonia patient with respiratory failure |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: Yes. We will share study protocol and Informed Consent Form and Clinical Study Report to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pin-Kuei Fu, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiota and Pneumonia, Bacterial, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.