Intestinal Microbiota and Antimicrobial Resistance

Drug Resistance, Microbial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794453
• Other study ID #: STM_protocol_v1_20180411
• Status: Recruiting
• Start date: August 6, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistance, Microbial

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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