Intestinal Bacteria Flora DisturbanceMARCNCT01591538
Multi-Antibiotic Resistance Carriage in Gut Flora
An observational study of Intestinal Bacteria Flora Disturbance, run by Da Volterra at 1 site in France.
Trial summary
Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Bacteria Flora Disturbance
- How many people
- 272 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers from French Armed Forces
Who may be able to join
- Being older than 18 years
- Have given an informed consent by signing the written consent
- Being able to give a stool sample
- Being member of military forces, supported medically by the French Military Health Services (SSA), and to participate outside mission during 4- 6 months
Who cannot join
- Participating in another biomedical study during the study
- Volunteer unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'épidémiologie et de santé publique des armées
Saint-Mandé, 94163
About this study
Official title: Prevalence Study Evaluating the Acquisition of Carriage of Resistant Bacteria in the Gut Flora in Volunteers From French Armed Forces Coming Back From External Operations
Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.
Read the detailed description
Emergence of MDRGN bacteria is blowing worldwide up leading to therapeutical failure in hospitalized patients with severe infections, as well as in outpatients with community-acquired infections such as UTI. Variation in prevalence exists across countries and regions. Travels outside own country of residence, like France, whatever the duration (short or long)or the reason (professional or leisure), are known risk factors for acquiring and disseminating MDRGN bacteria. Digestive carriage of multidrug-resistant Enterobacteriaceae could be a source of infection for the host as well as a source of dissemination. Qualitative and quantitative gut colonization by MDRGNB is poorly studied in non-hospitalized people who stayed for a few months out of France. The total amount of multidrug-resistant Enterobacteriaceae influences the spread of the dissemination. In our knowledge, no clinical study has been carried out to qualify and quantify gut colonization by MDRGNB in volunteers after staying 4-6 months outside country of residence such as France. A specific microbiological method will be evaluated in this study.
- Conditions
- Intestinal Bacteria Flora Disturbance
- Keywords
- Prevalence, MDRGNB, Acquisition, Middle stay, Endemic area
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 |
|---|---|---|
| lifestyle condition | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France
Measured: 12 months
Secondary outcomes (4)
Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France
Measured: 12 months
Quantitative variation of MDRGNB between the departure and return in volunteers
Measured: 12 months
PCR and sequencing of resistance genes from strains of interest
Measured: 12 months
Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Bacteria Flora DisturbanceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Da Volterra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste MEYNARD, MD/PhD, Principal investigator, French Armed Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591538
- Sponsor's protocol ID
- DAV148-EPI-01
- Other IDs
- ID RCB number : 2011-A01569-32
- Acronym
- MARC
- Status last verified
- May 2014
- First submitted
- 2 May 2012
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study Evaluating the Acquisition of Carriage of Resistant Bacteria in the Gut Flora in Volunteers From French Armed Forces Coming Back From External Operations
- ClinicalTrials.gov ID
- NCT01591538
- Acronym / sponsor ID
- MARC / DAV148-EPI-01
- Conditions
- Intestinal Bacteria Flora Disturbance
- Keywords
- Prevalence, MDRGNB, Acquisition, Middle stay, Endemic area
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Da VolterraIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 May 2012 (estimated)
- 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.
Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.
Detailed description
Emergence of MDRGN bacteria is blowing worldwide up leading to therapeutical failure in hospitalized patients with severe infections, as well as in outpatients with community-acquired infections such as UTI. Variation in prevalence exists across countries and regions. Travels outside own country of residence, like France, whatever the duration (short or long)or the reason (professional or leisure), are known risk factors for acquiring and disseminating MDRGN bacteria. Digestive carriage of multidrug-resistant Enterobacteriaceae could be a source of infection for the host as well as a source of dissemination. Qualitative and quantitative gut colonization by MDRGNB is poorly studied in non-hospitalized people who stayed for a few months out of France. The total amount of multidrug-resistant Enterobacteriaceae influences the spread of the dissemination. In our knowledge, no clinical study has been carried out to qualify and quantify gut colonization by MDRGNB in volunteers after staying 4-6 months outside country of residence such as France. A specific microbiological method will be evaluated in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle condition | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers from French Armed Forces
Key inclusion criteria (4 listed)
- Being older than 18 years
- Have given an informed consent by signing the written consent
- Being able to give a stool sample
- Being member of military forces, supported medically by the French Military Health Services (SSA), and to participate outside mission during 4- 6 months
Key exclusion criteria (2 listed)
- Participating in another biomedical study during the study
- Volunteer unable to give informed consent.
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
Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France
Time frame: 12 months
4 secondary outcomes
Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France
Time frame: 12 months
Quantitative variation of MDRGNB between the departure and return in volunteers
Time frame: 12 months
PCR and sequencing of resistance genes from strains of interest
Time frame: 12 months
Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France
Time frame: 12 months
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 29 May 2014.
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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.
Jean-Baptiste MEYNARD, MD/PhD principal investigator
French Armed Forces
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 Intestinal Bacteria Flora Disturbance, run by Da Volterra 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 4 inclusion and 2 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 29 May 2014. 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?
Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France (time frame: 12 months). 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 29 May 2014.