Intestinal Microbiota and Antimicrobial Resistance

NCT ID: NCT03794453

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke patients

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Grace Lui

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Facility Contacts

Grace Lui

Role: primary

gracelui@cuhk.edu.hk

35053376

Rity Wong

Role: backup

ritywong@cuhk.edu.hk

35053376

Other Identifiers

STM_protocol_v1_20180411

Identifier Type: -

Identifier Source: org_study_id