NCT06701890

Brief Summary

Traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.These conditions are associated with behavioral, geographical, or environmental risk factors. A better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues. The main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
11,000

participants targeted

Target at P75+ for not_applicable

Timeline
129mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress12%
Dec 2024Dec 2036

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2034

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

10 years

First QC Date

November 20, 2024

Last Update Submit

April 30, 2025

Conditions

Travel-Related Illness

Keywords

TravelRisk FactorsPathologyArbovirose

Outcome Measures

Primary Outcomes (1)

  • Determine the incidence of pathologies occurring during a travel outside the metropolitan territory.

    Number of subjects who developed a pathology during the travel among participants

    10 years

Secondary Outcomes (2)

  • For EOP-Arbo sub-study : Determine the prevalence for the occurrence of an arboviral disease (dengue, chikungunya, Zika) during the travel.

    10 years

  • For EOP-AMR sub-study : Determine the prevalence for the acquisition of multi-resistant bacteria (MRB) during the travel.

    10 years

Study Arms (1)

Adults planning to travel outside metropolitan France.

EXPERIMENTAL

Human biological samples : * Blood sample * fecal sample

Other: Blood sample collectionOther: Fecal sample collection

Interventions

Blood sample collectionOTHER

16 mL at inclusion 16 mL at 1 month after return from travel

Adults planning to travel outside metropolitan France.
Fecal sample collectionOTHER

1 sample at inclusion 1 sample at day 1, day 7, day 14, day 21, 1 month and 2 month after return from travel

Adults planning to travel outside metropolitan France.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all participants in the EOP study :
  • Major subject (age ≥ 18)
  • Owns a smartphone compatible with electronic data collection
  • Preparing to travel outside mainland France
  • Affiliated with or covered by Social Security or private insurance
  • Willing to participate in the EOP study
  • For the EOP-Arbo Sub-study :
  • \- Subject who has consented to participate in the EOP\_Arbo study.
  • For the EOP-AMR Sub-study :
  • Subject who has consented to participate in the EOP\_AMR study.

You may not qualify if:

  • For all participants in the EOP study :
  • Travel duration ≤ 3 days
  • Travel duration \> 12 months
  • Person traveling as part of an expatriation without planned movement outside the settlement in the destination country
  • Person under legal protection or unable to express consent for participation
  • For the EOP-Arbo Sub-study :
  • \- Individuals deemed clinically and/or biologically unfit by the investigator to undergo the blood samples required for the study.
  • For the EOP-AMR Sub-study :

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of Institut Pasteur

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Travel-Related Illness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fabien TAIEB, MD

    Medical Center of Institut Pasteur

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien TAIEB, MD

CONTACT

0140613456fabien.taieb@pasteur.fr

Julia ABAD

CONTACT

julia.abad@pasteur.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

December 9, 2024

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2036

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

FR(1)