Clinical trial NCT03794453: Intestinal Microbiota and Antimicrobial Resistance
Official title: Longitudinal Changes in Intestinal Microbiota and Its Association With Acquisition of Antimicrobial Resistance in a Cohort of Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Resistance, Microbial
Keywords: Stroke
Intestinal microbiota
Antimicrobial resistance
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of acute stroke

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.


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

Primary outcomes:
measure: Proportion of patients acquiring intestinal colonization of resistant organisms
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.
timeFrame: 2 years
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: