Antibiotics Resistance Gene in Healthcare Workers (ARGH)

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.

Study Overview

• Status: Completed
• Conditions: Multidrug Resistant Bacterial Infection
• Intervention / Treatment: Other: 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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• China
  • Jiaxing, China
    • The First Hospital of Jiaxing
  • Lishui, China
    • Lishui People's Hospital
  • Pinghu, China
    • The First People's Hospital of Pinghu
  • Taizhou, China
    • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • Zhengzhou, China
    • Henan Provincial People's Hospital
  • Zhengzhou, China
    • The Second Affiliated Hospital of Zhengzhou University
  • Zhengzhou, China
    • The Fifth Clinical Medical College of Henan University of Chinese Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • First Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

For medical workers:

Inclusion Criteria:

1. Age greater than 18 years old
2. The subjects fully understand and sign the informed consent form

Exclusion Criteria:

1. Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
2. Have taken broad-spectrum antibiotics within 6 months
3. Pregnant women

For healthy control:

Inclusion Criteria:

1. Age greater than 18 years old
2. The subjects fully understand and sign the informed consent form

Exclusion Criteria:

1. Previously or currently engaged in medical related work
2. Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
3. Have taken broad-spectrum antibiotics within 6 months
4. Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
medical worker; Medical workers working in clinical settings, including nurses, doctors, and Health care worker.	Other: metagenomics; Feces used for metagenomic testing
health population; Healthy individuals who do not engage in medical work	Other: metagenomics; Feces used for metagenomic testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Lingtong Huang, M.D., First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Actual): October 10, 2024
• Study Completion (Actual): November 10, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: IIT20230455B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Contact Dr. Lingtong Huang to obtain IPD data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No