Beta Lactam Resistant Bacterial Infection (Disorder)NCT03477760
Multi-Drug Resistant Bacteria Carriage After Travel
An observational study of Beta Lactam Resistant Bacterial Infection (Disorder), run by Hopital Lariboisière at 1 site in France.
Trial summary
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Beta Lactam Resistant Bacterial Infection (Disorder)
- What is being tested?
- rectal swab for Multi-Drug resistant bacteria
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Dec 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 patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year
Who may be able to join
- All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year
Who cannot join
- patients who were unable to give written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Drug Resistant Bacteria Carriage After Travel: Comparison Between Patients Who Have Been Hospitalized in a Foreign Country, or Not During the Previous Year
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent). They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel.
Read the detailed description
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent), regardless a travel in a foreign country during the past year, or not. They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel. The aim of the study will be to compare the rate of carriage of multi-drug resistant bacteria among previous travelers, or not.
- Being tested
- rectal swab for Multi-Drug resistant bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal swab for Multi-Drug resistant bacteriaBiological
A rectal swab will be performed at admission of patients to look for intestinal carriage of Multi-Drug resistant bacteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-Drug Resistant bacteria carriage rate
Multi-Drug Resistant bacteria carriage assessed by rectal swab
Measured: At admission in our Hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Lactam Resistant Bacterial Infection (Disorder)Studies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Célia Lloret-Linares, MD PhD, Hopital Lariboisière
- Investigators
- Pierre O Sellier, M.D., Ph.D., Study director, Hopital Lariboisiere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477760
- Sponsor's protocol ID
- MRB after travel
- Status last verified
- Mar 2018
- First submitted
- 18 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Drug Resistant Bacteria Carriage After Travel: Comparison Between Patients Who Have Been Hospitalized in a Foreign Country, or Not During the Previous Year
- ClinicalTrials.gov ID
- NCT03477760
- Acronym / sponsor ID
- MRB after travel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Mar 2018 (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.
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent). They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel.
Detailed description
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent), regardless a travel in a foreign country during the past year, or not. They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel. The aim of the study will be to compare the rate of carriage of multi-drug resistant bacteria among previous travelers, or not.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year
Key inclusion criteria (1 listed)
- All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year
Key exclusion criteria (1 listed)
- patients who were unable to give written consent
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 |
|---|---|---|
| rectal swab for Multi-Drug resistant bacteriaA rectal swab will be performed at admission of patients to look for intestinal carriage of Multi-Drug resistant bacteria | Biological | – |
Primary outcome
Multi-Drug Resistant bacteria carriage rate
Time frame: At admission in our Hospital
Multi-Drug Resistant bacteria carriage assessed by rectal swab
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 26 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Beta Lactam Resistant Bacterial Infection (Disorder)
Not yet recruitingObservational study
Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
Premature Rupture of Membranes, Enterobacteriaceae
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.
Pierre O Sellier, M.D., Ph.D. study director
Hopital Lariboisiere
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 Beta Lactam Resistant Bacterial Infection (Disorder), run by Hopital Lariboisière 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 1 inclusion and 1 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 26 Mar 2018. 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?
Multi-Drug Resistant bacteria carriage rate (time frame: At admission in our Hospital). 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 26 Mar 2018.