NCT04954300

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

June 29, 2021

Last Update Submit

May 31, 2023

Conditions

Hospital Acquired Infection

Keywords

Microbial ColonizationEnvironmental ExposureMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Community of microbiome in ICU

    the dynamic changes of metagenomic/16s sequencing data

    1 year and a half

Study Arms (3)

open

open: open ICU

Other: no intervention

negative

negative: negative-pressure laminar flow ward

Other: no intervention

positive

positive: laminar flow ward

Other: no intervention

Interventions

no interventionOTHER

No intervention

negativeopenpositive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

No patients were enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: NONE RETAINED

We collected the air samples in 3 different ICU.

MeSH Terms

Conditions

Cross InfectionCommunicable Diseases

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yuxin Leng, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

June 2, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)