Hospital Acquired InfectionNCT04954300
Investigation on the Dynamic Changes in Air Microbiome in Intensive Care Unit
An observational study of Hospital Acquired Infection, run by Peking University Third Hospital at 1 site in China.
Trial summary
The microbiome of ICU, especially the air microbiome of ICU is not clear. The relationship between the microbiome of ICU and the hospital- acquired infection needs to be clarified. In this study, we try to outline the dynamic changes of microbiome in ICU and give some advice on the prevention of HAI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital Acquired Infection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: No patients were enrolled in this study.
Inclusion criteria: no patients were enrolled in this study. Exclusion criteria: no patients were enrolled in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
The microbiome of ICU, especially the air microbiome of ICU is not clear. The relationship between the microbiome of ICU and the hospital- acquired infection needs to be clarified. In this study, we try to outline the dynamic changes of microbiome in ICU and give some advice on the prevention of HAI.
- Conditions
- Hospital Acquired Infection
- Being tested
- no intervention
- Keywords
- Microbial Colonization, Environmental Exposure, Microbiome
- Medical subject headings
- Cross Infection, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| open | open: open ICU Receives: Other: no intervention | |
| negative | negative: negative-pressure laminar flow ward Receives: Other: no intervention | |
| positive | positive: laminar flow ward Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community of microbiome in ICU
the dynamic changes of metagenomic/16s sequencing data
Measured: 1 year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Acquired InfectionStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuxin Leng, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954300
- Sponsor's protocol ID
- LM2021076
- Status last verified
- May 2022
- First submitted
- 29 Jun 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Dynamic Changes in Air Microbiome in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04954300
- Acronym / sponsor ID
- LM2021076
- Conditions
- Hospital Acquired Infection
- Keywords
- Microbial Colonization, Environmental Exposure, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 Jul 2021 (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.
The microbiome of ICU, especially the air microbiome of ICU is not clear. The relationship between the microbiome of ICU and the hospital- acquired infection needs to be clarified. In this study, we try to outline the dynamic changes of microbiome in ICU and give some advice on the prevention of HAI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| open | – | Other: no interventionopen: open ICU |
| negative | – | Other: no interventionnegative: negative-pressure laminar flow ward |
| positive | – | Other: no interventionpositive: laminar flow ward |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No patients were enrolled in this study.
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 |
|---|---|---|
| no interventionNo intervention | Other | negative, open, positive |
Primary outcome
Community of microbiome in ICU
Time frame: 1 year and a half
the dynamic changes of metagenomic/16s sequencing data
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 2 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Yuxin Leng, PhD principal investigator
Peking University Third 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 Hospital Acquired Infection, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. 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 China. 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?
Community of microbiome in ICU (time frame: 1 year and a half). 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 2 Jun 2023.