Intestinal Microbiota and Antimicrobial Resistance

NCT03794453 | Unknown

• 1 other identifier: STM_protocol_v1_20180411
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistance, Microbial

Keywords

Stroke; Intestinal microbiota; Antimicrobial resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.

  2 years

Study Arms (1)

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of acute stroke

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples for microbiota analysis

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: August 6, 2018
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)