NCT01591538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

May 2, 2012

Last Update Submit

May 28, 2014

Conditions

Intestinal Bacteria Flora Disturbance

Keywords

PrevalenceMDRGNBAcquisitionMiddle stayEndemic area

Outcome Measures

Primary Outcomes (1)

  • Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France

    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

    12 months

  • Quantitative variation of MDRGNB between the departure and return in volunteers

    12 months

  • PCR and sequencing of resistance genes from strains of interest

    12 months

  • Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France

    12 months

Study Arms (1)

lifestyle condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers from French Armed Forces

You may qualify if:

  • 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

You may not qualify if:

  • Participating in another biomedical study during the study
  • Volunteer unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'épidémiologie et de santé publique des armées

Saint-Mandé, 94163, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

Study Officials

  • Jean-Baptiste MEYNARD, MD/PhD

    French Armed Forces

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 4, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

FR(1)