Hospital Acquired InfectionNCT05877625
Study on Dynamic Environmental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host
An observational study of Hospital Acquired Infection and Ventilator-associated Pneumonia, run by Peking University Third Hospital at 1 site in China.
Trial summary
HAI (Hospital-acquired infection) is very common in ICU，and lack of understanding of environmental exposure omics and environment-host microbial interactions restricts the prevention and control of HAI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Infection, Ventilator-associated Pneumonia
- What is being tested?
- Expectoration care
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Aug 2023
- How long will I take part?
- 90 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mechanical ventilation, age ≥18 years, anticipated ICU stay for more than 2 days, and with two or more of the following ventilator-associated pneumonia (VAP) risk factors were included in this study.
Who may be able to join
- With mechanical ventilation
- Age ≥18 years
- Anticipated ICU stay for more than 2 days
- With two or more of the following ventilator-associated pneumonia (VAP) risk factors
- VAP risk factors: Age ≥ 60 years old; Patients with chronic lung disease; Long-term bedridden; Unconsciousness; Sputum is not easily coughed up; Antibiotics have been used before mechanical ventilation; Long-term use of H receptor blockers and proton pump inhibitors.
Who cannot join
- Patients who have not signed the informed consent
- Pregnant
- Systemic diseases and recent use of related drugs
- History of infectious diseases, such as tuberculosis or PPD positive
- History of hypertension and poor blood pressure control (SBP / DBP > = 140mmHg)
- With severe mental illness
- Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
HAI (Hospital-acquired infection) is very common in ICU，and lack of understanding of environmental exposure omics and environment-host microbial interactions restricts the prevention and control of HAI. In this project, the investigators try to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment through metagenome.
Read the detailed description
This observational study aims to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment. The investigators will conduct weekly air microbiome sampling and microbiome sampling at 5 high-frequency contact points in different types of ICU units in three hospitals for one consecutive year, and collect dynamic pharyngeal swabs from ICU ward health care workers and dynamic clinical specimens (endotracheal aspiration, and bronchoalveolar lavage fluid) from patients with ventilator-associated pneumonia in ICU ward. With DNA high-throughput sequencing technology, the investigators will analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment, and provide support for HAI prevention.
- Being tested
- Expectoration care
- Keywords
- Environment exposure, Microbial Colonization, Microbiome
- Medical subject headings
- Cross Infection, Pneumonia, Ventilator-Associated, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectoration careProcedure or surgery
Also called Bronchoscope, Oropharyngeal swabs
- Endotracheal aspiration: from discarded samples after expectoration care
- BALF (bronchoalveolar lavage fluid): if patients with fiber bronchoscope examination, take the rest of the BALF after examination
- Oropharyngeal swabs
| Study group | Role | What they receive |
|---|---|---|
| open ICU | open ICU: open ICU Receives: Procedure: Expectoration care | |
| negative ICU | negative ICU: negative-pressure laminar flow ward Receives: Procedure: Expectoration care | |
| positive ICU | positive ICU: laminar flow ward Receives: Procedure: Expectoration care |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
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
- 180 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877625
- Sponsor's protocol ID
- M2022419
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Dynamic Environmental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host
- ClinicalTrials.gov ID
- NCT05877625
- Acronym / sponsor ID
- M2022419
- Keywords
- Environment exposure, Microbial Colonization, Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Zhejiang University, Central South University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 26 May 2023 (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.
HAI (Hospital-acquired infection) is very common in ICU，and lack of understanding of environmental exposure omics and environment-host microbial interactions restricts the prevention and control of HAI. In this project, the investigators try to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment through metagenome.
Detailed description
This observational study aims to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment. The investigators will conduct weekly air microbiome sampling and microbiome sampling at 5 high-frequency contact points in different types of ICU units in three hospitals for one consecutive year, and collect dynamic pharyngeal swabs from ICU ward health care workers and dynamic clinical specimens (endotracheal aspiration, and bronchoalveolar lavage fluid) from patients with ventilator-associated pneumonia in ICU ward. With DNA high-throughput sequencing technology, the investigators will analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment, and provide support for HAI prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| open ICU | – | Procedure: Expectoration careopen ICU: open ICU |
| negative ICU | – | Procedure: Expectoration carenegative ICU: negative-pressure laminar flow ward |
| positive ICU | – | Procedure: Expectoration carepositive ICU: laminar flow ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mechanical ventilation, age ≥18 years, anticipated ICU stay for more than 2 days, and with two or more of the following ventilator-associated pneumonia (VAP) risk factors were included in this study.
Key inclusion criteria (5 listed)
- With mechanical ventilation
- Age ≥18 years
- Anticipated ICU stay for more than 2 days
- With two or more of the following ventilator-associated pneumonia (VAP) risk factors
- VAP risk factors: Age ≥ 60 years old; Patients with chronic lung disease; Long-term bedridden; Unconsciousness; Sputum is not easily coughed up; Antibiotics have been used before mechanical ventilation; Long-term use of H receptor blockers and proton pump inhibitors.
Key exclusion criteria (7 listed)
- Patients who have not signed the informed consent
- Pregnant
- Systemic diseases and recent use of related drugs
- History of infectious diseases, such as tuberculosis or PPD positive
- History of hypertension and poor blood pressure control (SBP / DBP > = 140mmHg)
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 |
|---|---|---|
| Expectoration careAlso: Bronchoscope, Oropharyngeal swabs1. Endotracheal aspiration: from discarded samples after expectoration care 2. BALF (bronchoalveolar lavage fluid): if patients with fiber bronchoscope examination, take the rest of the BALF after examination 3. Oropharyngeal swabs | Procedure or surgery | negative ICU, open ICU, positive ICU |
Primary outcome
Community of microbiome in ICU
Time frame: 1 year
the dynamic changes of metagenomic/16s sequencing data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Related trials for Hospital Acquired Infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Ventilator-associated Pneumonia, 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.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 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?
Results are not available in the source record.
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). 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 22 Jun 2023.