Drug Resistance, MicrobialNCT03794453
Intestinal Microbiota and Antimicrobial Resistance
An observational study of Drug Resistance, Microbial, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistance, Microbial
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Aug 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a diagnosis of acute stroke
Who may be able to join
- Adults aged 18 years or above, and
- Radiological evidence of acute ischaemic or hemorrhagic stroke
- Within two days of hospital admission
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Grace Lui, 35053376, gracelui@cuhk.edu.hk
Rity Wong, 35053376, ritywong@cuhk.edu.hk
About this study
Official title: Longitudinal Changes in Intestinal Microbiota and Its Association With Acquisition of Antimicrobial Resistance in a Cohort of Stroke Patients
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.
Read more
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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start6 Aug 2018
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistance, MicrobialStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794453
- Sponsor's protocol ID
- STM_protocol_v1_20180411
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2019
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Intestinal Microbiota and Its Association With Acquisition of Antimicrobial Resistance in a Cohort of Stroke Patients
- ClinicalTrials.gov ID
- NCT03794453
- Acronym / sponsor ID
- STM_protocol_v1_20180411
- Conditions
- Drug Resistance, Microbial
- Keywords
- Stroke, Intestinal microbiota, Antimicrobial resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of acute stroke
Key inclusion criteria (3 listed)
- Adults aged 18 years or above, and
- Radiological evidence of acute ischaemic or hemorrhagic stroke
- Within two days of hospital admission
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients acquiring intestinal colonization of resistant organisms
Time frame: 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.
1 secondary outcome
Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistance, Microbial, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients acquiring intestinal colonization of resistant organisms (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.