Intestinal Microbiota and Antimicrobial Resistance

Recruiting

• Conditions: Drug Resistance, Microbial

• Registration Number: NCT03794453
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-06
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-05-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients acquiring intestinal colonization of resistant organisms	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.	2 years	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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong