Clinical trial NCT06228248: Antibiotics Resistance Gene in Healthcare Workers
Official title: Characterizing the Differences in Gut Microbiome Antibiotics Resistance Gene Between Healthcare Workers and the Healthy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multidrug Resistant Bacterial Infection
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in GUT ARG abundance between two groups
timeFrame: 1 year
Secondary outcomes:
measure: The association of occupational exposure time in the ICU environment and ARG
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Lishui
country: China
facility: Lishui People's Hospital
city: Pinghu
country: China
facility: The First People's Hospital of Pinghu
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: The Fifth Clinical Medical College of Henan University of Chinese Medicine
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Lingtong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: