Travel MedicineMDR bacteriaNCT03339947
French Travelers' Knowledge of Risk of Acquiring ESBL-PE
An observational study of Travel Medicine, run by CHU de Reims at 1 site in France.
Trial summary
Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the investigators aimed to determine, among French travelers attending a consultation for travel medicine, patients level of knowledge about the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Travel Medicine
- What is being tested?
- Questionnaire
- Type of treatment
- Vaccines
- How many people
- 191 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Jun 2016
- 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: All adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital between January 2016 and May 2016 and who completed the questionnaire were included in the study.
Who may be able to join
- Adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital
- Adult who completed the questionnaire
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Poor Knowledge Among French Travelers of the Risk of Acquiring Multidrug-resistant Bacteria During Travel
Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the investigators aimed to determine, among French travelers attending a consultation for travel medicine, patients level of knowledge about the risk of acquiring MRE.
Read the detailed description
Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, The investigators aimed to assess, among persons attending a consultation for travel medicine and international vaccines, patients level of knowledge regarding the risk of acquiring MRE, preventive behaviours and the need to inform health professionals that they had recently travelled if the patients require medical care after their return. A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who attended this consultation between January 2016 and May 2016 and who completed the questionnaire were included in the study. The questionnaire was completed before the planned travel. The travellers answered the questionnaires before seeing the physician.
- Conditions
- Travel Medicine
- Being tested
- Questionnaire
- Keywords
- Multidrug-resistant Enterobacteriaceae acquisition, travellers' diarrhoea, international travel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Travel medicine | All adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of knowledge regarding multidrug resistant Enterobacteriaceae
The questionnaire was completed before the planned travel and recorded information on the patient's knowledge of the definition of multidrug resistant bacteria (MDR), knowledge of the factors associated with acquiring MDR bacteria, consumption of antibiotics during previous travel, awareness of the need to inform health professionals about the recent trip in case of health problems after return, perceived need for more information about MDR bacteria, desired source of such information. The questions about knowledge were designed to be as simple as possible, with closed answers ('yes', 'no', 'don't know')
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Jan 2016
- Primary completion1 May 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Travel MedicineStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339947
- Sponsor's protocol ID
- 2016Ao006
- Acronym
- MDR bacteria
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Migault C, Kanagaratnam L, Nguyen Y, Lebrun D, Giltat A, Hentzien M, Bajolet O, Drame M, Bani-Sadr F. Poor knowledge among French travellers of the risk of acquiring multidrug-resistant bacteria during travel. J Travel Med. 2016 Oct 30;24(1):taw073. doi: 10.1093/jtm/taw073. Print 2016 Jul. No abstract available.
PubMed 27799500
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poor Knowledge Among French Travelers of the Risk of Acquiring Multidrug-resistant Bacteria During Travel
- ClinicalTrials.gov ID
- NCT03339947
- Acronym / sponsor ID
- MDR bacteria / 2016Ao006
- Conditions
- Travel Medicine
- Keywords
- Multidrug-resistant Enterobacteriaceae acquisition, travellers' diarrhoea, international travel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 13 Nov 2017 (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.
Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the investigators aimed to determine, among French travelers attending a consultation for travel medicine, patients level of knowledge about the risk of acquiring MRE.
Detailed description
Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, The investigators aimed to assess, among persons attending a consultation for travel medicine and international vaccines, patients level of knowledge regarding the risk of acquiring MRE, preventive behaviours and the need to inform health professionals that they had recently travelled if the patients require medical care after their return. A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who attended this consultation between January 2016 and May 2016 and who completed the questionnaire were included in the study. The questionnaire was completed before the planned travel. The travellers answered the questionnaires before seeing the physician.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Travel medicine | – | Other: QuestionnaireAll adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital between January 2016 and May 2016 and who completed the questionnaire were included in the study.
Key inclusion criteria (2 listed)
- Adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital
- Adult who completed the questionnaire
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire | Other | Travel medicine |
Primary outcome
Level of knowledge regarding multidrug resistant Enterobacteriaceae
Time frame: Day 1
The questionnaire was completed before the planned travel and recorded information on the patient's knowledge of the definition of multidrug resistant bacteria (MDR), knowledge of the factors associated with acquiring MDR bacteria, consumption of antibiotics during previous travel, awareness of the need to inform health professionals about the recent trip in case of health problems after return, perceived need for more information about MDR bacteria, desired source of such information. The questions about knowledge were designed to be as simple as possible, with closed answers ('yes', 'no', 'don't know')
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 13 Nov 2017.
- Background: PubMed 27799500Migault C, Kanagaratnam L, Nguyen Y, Lebrun D, Giltat A, Hentzien M, Bajolet O, Drame M, Bani-Sadr F. Poor knowledge among French travellers of the risk of acquiring multidrug-resistant bacteria during travel. J Travel Med. 2016 Oct 30;24(1):taw073. doi: 10.1093/jtm/taw073. Print 2016 Jul. No abstract available.
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 Travel Medicine, run by CHU de Reims at 1 site in France.
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 2 inclusion and 0 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 13 Nov 2017. 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 France. 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?
Level of knowledge regarding multidrug resistant Enterobacteriaceae (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339947, which also lists 1 linked publication.
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 13 Nov 2017.