Antimicrobial ResistanceNCT03794479
Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel
An observational study of Antimicrobial Resistance, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Resistance
- How many people
- 125 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Nov 2018to 6 Jun 2023
- 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: Adults planning for travel
Who may be able to join
- Adults aged 18 years or above
- Chinese ethnicity
- Planning to visit any places outside of Hong Kong within the next three months
- Able to provide informed consent
Who cannot join
- Use of antibiotics within 4 weeks prior to the time of recruitment (Except for antimalarial prophylaxis)
- Hospitalization within 3 months
- 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.
About this study
Official title: Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel
International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant organisms had been demonstrated to be associated with distinct intestinal microbiota composition and travellers constitute a generally healthy population with minimal antibiotics exposure; by evaluating serial stool samples before and after travel, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.
- Conditions
- Antimicrobial Resistance
- Keywords
- Intestinal microbiota, Antimicrobial resistance
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 |
|---|---|---|
| Travellers | Adults planning for travel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae
Intestinal colonization of ESBL-producing Enterobacteriaceae is defined as the presence of ESBL in Enterobacteriaceae identified in the post-travel stool samples, in patients without these organisms detected in their stool samples before travel.
Measured: 1 year
Secondary outcomes (1)
Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae
Intestinal colonization of carbapenem-resistant Enterobacteriaceae is defined as the presence of carbapenem-resistant Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples before travel.
Measured: 1 year
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 start5 Nov 2018
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial ResistanceStudies 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
- 125 participants (actual)
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
- NCT03794479
- Sponsor's protocol ID
- travellers_version 2_20180724
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2019
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel
- ClinicalTrials.gov ID
- NCT03794479
- Acronym / sponsor ID
- travellers_version 2_20180724
- Conditions
- Antimicrobial Resistance
- Keywords
- Intestinal microbiota, Antimicrobial resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- 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.
International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant organisms had been demonstrated to be associated with distinct intestinal microbiota composition and travellers constitute a generally healthy population with minimal antibiotics exposure; by evaluating serial stool samples before and after travel, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Travellers | – | –Adults planning for travel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults planning for travel
Key inclusion criteria (4 listed)
- Adults aged 18 years or above
- Chinese ethnicity
- Planning to visit any places outside of Hong Kong within the next three months
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Use of antibiotics within 4 weeks prior to the time of recruitment (Except for antimalarial prophylaxis)
- Hospitalization within 3 months
- 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 ESBL-producing Enterobacteriaceae
Time frame: 1 year
Intestinal colonization of ESBL-producing Enterobacteriaceae is defined as the presence of ESBL in Enterobacteriaceae identified in the post-travel stool samples, in patients without these organisms detected in their stool samples before travel.
1 secondary outcome
Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Antimicrobial Resistance, 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 4 inclusion and 4 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae (time frame: 1 year). 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.