Antibiotics Resistance Gene in Healthcare Workers

NCT06228248 | Completed

• 1 other identifier: IIT20230455B
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

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.

Conditions

Multidrug Resistant Bacterial Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The association of occupational exposure time in the ICU environment and ARG

  1 year

Study Arms (2)

medical worker

Medical workers working in clinical settings, including nurses, doctors, and Health care worker.

Other: metagenomics

health population

Healthy individuals who do not engage in medical work

Other: metagenomics

Interventions

metagenomics OTHER

Feces used for metagenomic testing

health population; medical worker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
• Have taken broad-spectrum antibiotics within 6 months
• Pregnant women
• For healthy control:
• Age greater than 18 years old
• The subjects fully understand and sign the informed consent form
• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (8)

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

The First Hospital of Jiaxing

Jiaxing, China

Location

Lishui People's Hospital

Lishui, China

Location

The First People's Hospital of Pinghu

Pinghu, China

Location

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

The Fifth Clinical Medical College of Henan University of Chinese Medicine

Zhengzhou, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Related Publications (1)

• 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.

  PMID: 40307838 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal specimens are used for extracting DNA and conducting metagenomic sequencing

Study Officials

• Lingtong Huang, M.D.

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 29, 2024
• Study Start: January 18, 2024
• Primary Completion: October 10, 2024
• Study Completion: November 10, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-02

Locations

CN (8)