Multidrug Resistant Bacterial InfectionARGHNCT06228248
Antibiotics Resistance Gene in Healthcare Workers
An observational study of Multidrug Resistant Bacterial Infection, run by First Affiliated Hospital of Zhejiang University at 8 sites in China.
Trial summary
Multidrug resistant bacteria (MDR) pose a threat to the safety of patients worldwide. Drug resistant bacteria are commonly present in hospital environments and can cause infections, often leading to outbreaks within hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidrug Resistant Bacterial Infection
- What is being tested?
- metagenomics
- How many people
- 250 participants
- Where
- 8 sitesChina
- Study dates
- 18 Jan 2024to 10 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included medical workers and health control. The investigator excluded underlying diseases that may have an impact on the gut microbiome, and also excluded individuals who had used broad-spectrum antibiotics within 6 months.
Who may be able to join
- Age greater than 18 years old
- The subjects fully understand and sign the informed consent form
- Age greater than 18 years old
- The subjects fully understand and sign the informed consent form
Who cannot join
- Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
- Have taken broad-spectrum antibiotics within 6 months
- Pregnant women
- For healthy control:
- Previously or currently engaged in medical related work
- Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
- Have taken broad-spectrum antibiotics within 6 months
- Pregnant women
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
The First Hospital of Jiaxing
Jiaxing
Lishui People's Hospital
Lishui
The First People's Hospital of Pinghu
Pinghu
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou
Henan Provincial People's Hospital
Zhengzhou
The Fifth Clinical Medical College of Henan University of Chinese Medicine
Zhengzhou
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Characterizing the Differences in Gut Microbiome Antibiotics Resistance Gene Between Healthcare Workers and the Healthy Population
Multidrug resistant bacteria (MDR) pose a threat to the safety of patients worldwide. Drug resistant bacteria are commonly present in hospital environments and can cause infections, often leading to outbreaks within hospitals. Cross transmission through medical staff has been proven to be a significant cause of MDR bacterial transmission in hospitals. Although some studies have shown that the detection of gut drug-resistant bacteria in healthcare workers is similar to that in healthy individuals, these studies are limited to small sample sizes and detection methods. Here, the investigator characterize the differences between ARG colonization among healthcare workers and healthy populations through deep metagenomics.
Read the detailed description
Understanding the antibiotic resistant genes in the intestinal microbiome of medical workers can reveal their exposure history to antibiotics and the status of antibiotic resistance. The gut microbiome of medical staff may be one of the important sources of MDR transmission. The contact between medical staff and patients is one of the main ways of MDR transmission in hospitals. Understanding the types and distribution of antibiotic resistant genes of gut microbiome of medical workers can assess the risk of MDR transmission in the hospital, help to assess them as the potential source of MDR transmission, and then take targeted prevention and control measures.
In order to better understand the role of medical staff in the transmission of MDR, it is necessary to conduct research on larger sample size and more sensitive detection methods. Metagenomics studies the genomes of all microorganisms in the microbial ecological community. It constructs a metagenomic library by directly extracting the DNA or RNA of all microorganisms from environmental samples, studies the species composition and functional composition of the community, the interaction of different microorganisms in the same population, and the interaction between microbial communities and hosts, and makes a comparative analysis of samples with different phenotypes. With the characteristics of high data flux, low cost and fast speed, it has become a powerful tool for the study of gut microbe.
To sum up, MDR poses a serious threat to global security. In order to deal with this problem, more in-depth and comprehensive research is needed to understand the transmission route of MDR in the hospital. The investigator evaluated the difference between the gut microbe antibiotic resistant genes abundance of medical workers, especially medical workers in the ICU, and healthy people through in-depth sequencing, which helps to provide information on the potential role of medical staff in the transmission of MDR, and is essential for formulating effective prevention and control strategies.
- Conditions
- Multidrug Resistant Bacterial Infection
- Being tested
- metagenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metagenomicsOther
Feces used for metagenomic testing
| Study group | Role | What they receive |
|---|---|---|
| medical worker | Medical workers working in clinical settings, including nurses, doctors, and Health care worker. Receives: Other: metagenomics | |
| health population | Healthy individuals who do not engage in medical work Receives: Other: metagenomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in GUT ARG abundance between two groups
After conducting metagenomic testing, the investigator will analyze the raw data according to the preset protocol process and report the gut ARG abundance of different individuals. Subsequently, the difference in ARG abundance between the two groups of patients will be compared.
Measured: 1 year
Secondary outcomes (1)
The association of occupational exposure time in the ICU environment and ARG
After conducting metagenomic testing, the investigator will analyze the raw data according to the preset protocol process and report the gut ARG abundance of different individuals. Subsequently, the investigator will assess the correlation between occupational exposure time in the ICU environment and ARGs abundance of two groups.
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 posted29 Jan 2024
- Study start18 Jan 2024
- Primary completion10 Oct 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multidrug Resistant Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 250 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingtong Huang, MD, First Affiliated Hospital of Zhejiang University
- Investigators
- Lingtong Huang, M.D., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228248
- Sponsor's protocol ID
- IIT20230455B
- Acronym
- ARGH
- Status last verified
- Feb 2024
- First submitted
- 2 Jan 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contact Dr. Lingtong Huang to obtain IPD data
Publications
Huang L, Li K, Peng C, Gu S, Huang X, Gao C, Ren X, Cheng M, He G, Xu Y, Jiang Y, Wang H, Wang M, Shen P, Wang Q, He X, Zhong L, Wang S, Wang N, Zhang G, Cai H, Jiang C. Elevated antibiotic resistance gene abundance of ICU healthcare workers, a multicentre, cross-sectional study. Crit Care. 2025 Apr 30;29(1):170. doi: 10.1186/s13054-025-05408-5.
PubMed 40307838
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Differences in Gut Microbiome Antibiotics Resistance Gene Between Healthcare Workers and the Healthy Population
- ClinicalTrials.gov ID
- NCT06228248
- Acronym / sponsor ID
- ARGH / IIT20230455B
- Conditions
- Multidrug Resistant Bacterial Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 29 Jan 2024 (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.
Multidrug resistant bacteria (MDR) pose a threat to the safety of patients worldwide. Drug resistant bacteria are commonly present in hospital environments and can cause infections, often leading to outbreaks within hospitals. Cross transmission through medical staff has been proven to be a significant cause of MDR bacterial transmission in hospitals. Although some studies have shown that the detection of gut drug-resistant bacteria in healthcare workers is similar to that in healthy individuals, these studies are limited to small sample sizes and detection methods. Here, the investigator characterize the differences between ARG colonization among healthcare workers and healthy populations through deep metagenomics.
Detailed description
Understanding the antibiotic resistant genes in the intestinal microbiome of medical workers can reveal their exposure history to antibiotics and the status of antibiotic resistance. The gut microbiome of medical staff may be one of the important sources of MDR transmission. The contact between medical staff and patients is one of the main ways of MDR transmission in hospitals. Understanding the types and distribution of antibiotic resistant genes of gut microbiome of medical workers can assess the risk of MDR transmission in the hospital, help to assess them as the potential source of MDR transmission, and then take targeted prevention and control measures.
In order to better understand the role of medical staff in the transmission of MDR, it is necessary to conduct research on larger sample size and more sensitive detection methods. Metagenomics studies the genomes of all microorganisms in the microbial ecological community. It constructs a metagenomic library by directly extracting the DNA or RNA of all microorganisms from environmental samples, studies the species composition and functional composition of the community, the interaction of different microorganisms in the same population, and the interaction between microbial communities and hosts, and makes a comparative analysis of samples with different phenotypes. With the characteristics of high data flux, low cost and fast speed, it has become a powerful tool for the study of gut microbe.
To sum up, MDR poses a serious threat to global security. In order to deal with this problem, more in-depth and comprehensive research is needed to understand the transmission route of MDR in the hospital. The investigator evaluated the difference between the gut microbe antibiotic resistant genes abundance of medical workers, especially medical workers in the ICU, and healthy people through in-depth sequencing, which helps to provide information on the potential role of medical staff in the transmission of MDR, and is essential for formulating effective prevention and control strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical worker | – | Other: metagenomicsMedical workers working in clinical settings, including nurses, doctors, and Health care worker. |
| health population | – | Other: metagenomicsHealthy individuals who do not engage in medical work |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included medical workers and health control. The investigator excluded underlying diseases that may have an impact on the gut microbiome, and also excluded individuals who had used broad-spectrum antibiotics within 6 months.
Key inclusion criteria (4 listed)
- Age greater than 18 years old
- The subjects fully understand and sign the informed consent form
- Age greater than 18 years old
- The subjects fully understand and sign the informed consent form
Key exclusion criteria (8 listed)
- Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
- Have taken broad-spectrum antibiotics within 6 months
- Pregnant women
- Previously or currently engaged in medical related work
- Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
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 |
|---|---|---|
| metagenomicsFeces used for metagenomic testing | Other | health population, medical worker |
Primary outcome
Differences in GUT ARG abundance between two groups
Time frame: 1 year
After conducting metagenomic testing, the investigator will analyze the raw data according to the preset protocol process and report the gut ARG abundance of different individuals. Subsequently, the difference in ARG abundance between the two groups of patients will be compared.
1 secondary outcome
The association of occupational exposure time in the ICU environment and ARG
Time frame: 1 year
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 26 Feb 2025.
- Derived from this study: PubMed 40307838Huang L, Li K, Peng C, Gu S, Huang X, Gao C, Ren X, Cheng M, He G, Xu Y, Jiang Y, Wang H, Wang M, Shen P, Wang Q, He X, Zhong L, Wang S, Wang N, Zhang G, Cai H, Jiang C. Elevated antibiotic resistance gene abundance of ICU healthcare workers, a multicentre, cross-sectional study. Crit Care. 2025 Apr 30;29(1):170. doi: 10.1186/s13054-025-05408-5.
- Individual participant dataSharing planned: Undecided. Contact Dr. Lingtong Huang to obtain IPD data
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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.
Lingtong Huang, M.D. principal investigator
First Affiliated Hospital of Zhejiang University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug Resistant Bacterial Infection, run by First Affiliated Hospital of Zhejiang University at 8 sites 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 4 inclusion and 8 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Differences in GUT ARG abundance between two groups (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228248, which also lists 1 linked publication.
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 26 Feb 2025.