Intestinal Microbiota and Antimicrobial Resistance

Longitudinal Changes in Intestinal Microbiota and Its Association With Acquisition of Antimicrobial Resistance in a Cohort of Stroke Patients

Antimicrobial resistance is regarded as one of the major global public health threats, causing at least 700,000 deaths per year. It has been estimated that if the current problem of antimicrobial resistance is not effectively tackled, it would cause the death of 10 million people worldwide by 2050. Multi-drug resistant pathogen is the single most important contributing factor for inappropriate antibiotics therapy, and this in turn lead to higher mortality in patients with sepsis. The slow pace of development of new classes of antimicrobial agents limits the availability of effective therapy for multi-drug resistant organisms, both currently and in the near future. It is therefore of utmost importance to look for strategies to reduce the spread and burden of antimicrobial resistance.

Intestinal microbiota probably played a dominant role in determining the risk of acquisition of multi-drug resistant organisms. For instance, findings from a mouse model showed that Barnesiella species conferred resistance to intestinal colonization by vancomycinresistant Enterococcus. Such findings were subsequently confirmed in human subjects.

This is a prospective longitudinal observational study evaluating the correlation between changes in intestinal microbiota and acquisition of antimicrobial resistance in patients hospitalized for stroke.

Adult patients admitted to the Medical unit of the Prince of Wales Hospital with a diagnosis of acute stroke will be screened for eligibility and will be invited to participate in this study. Data collected from this study will determine the correlation between antibiotics use and changes in intestinal microbiota in a cohort of hospitalized patients as well as the correlation between intestinal microbiota and acquisition of intestinal colonization or infection caused by resistant pathogens.

Study Overview

• Status: Recruiting
• Conditions: Drug Resistance, Microbial

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Grace Lui; Phone Number: 35053376; Email: gracelui@cuhk.edu.hk
    • Contact: Rity Wong; Phone Number: 35053376; Email: ritywong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of acute stroke

Description

Inclusion Criteria:

• Adults aged 18 years or above, and
• Radiological evidence of acute ischaemic or hemorrhagic stroke
• Within two days of hospital admission

Exclusion Criteria:

• Use of antibiotics within 4 weeks prior to the time of screening
• Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients acquiring intestinal colonization of resistant organisms	Intestinal colonization of resistant organisms are defined as the presence of ESBL or resistance to one or more carbapenems in Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples at the time of admission to hospital.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.	Nosocomial infections are defined as infections with onset of 72 hours or more after hospital admission. Multi-drug resistant pathogens are defined as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus species, ESBL-producing Enterobacteriaceae, and carbapenem-resistant Gram-negative bacteria, including Enterobacteriaceae, Acinetobacter species, and Pseudomonas aeruginosa, detected in one or more of patients' clinical specimens.	2 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Intestinal microbiota; Antimicrobial resistance
• Other Study ID Numbers: STM_protocol_v1_20180411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No