Infection Tracking in Travellers. The Project Aims to Identify Profiles of Travel-associated Illness and to Follow up on Long-term Sequelae of Arboviral Infections and Malaria (ITIT)

December 16, 2020 updated by: Patricia Schlagenhauf

Infection Tracking in Travellers (ITIT)

The investigators hypothesize that sex, age, area of exposure and purpose of travel are associated with different travel-related infections. The investigators also hypothesize that certain infections will have long-term sequelae.

Health-data will be collected from travellers from Switzerland and Europe. The project starts with a pilot study for 50 travellers, followed by the recruiting of 10,000 travellers. The data collection will be via a mobile App (ITIT). The ITIT App will collect active data from travellers. The participants will download the App after signing an electronic consent form and completing a baseline questionnaire. Then the travellers will answer a short daily questionnaire about illness symptoms during travel. The ITIT App will also collect passive data (GPS localisation, environmental and weather data). The project will provide real-time data on travel-related infections and profile travel illness by age, sex and purpose of travel and also identify outbreaks.

Study Overview

Detailed Description

International travel is growing exponentially. Globally, there will be a projected 1.8 billion traveller arrivals in 2030. Current surveillance of travellers' health is top-down (i.e., clinicians/laboratories report illness) and only a small proportion of illness events are captured. More data are needed on the types of infections acquired by different groups who have varying purposes of travel such as business/corporate travellers, those visiting friends and relatives (VFR), leisure/tourist travellers and mass gathering event (Hajj, Olympics, World Cup) attendees. More data are needed to profile infections in travellers according to age and sex as men and women have different infection susceptibilities. Infectious diseases, in particular the spread of malaria and "arboviral infections",(i.e. viruses such as dengue) pose major threats with changing epidemiology influenced by climate, environmental factors and human mobility. The extent and impact of these infections on travellers' health and their long-term sequelae have scarcely been evaluated. The collected data will allow the profiling of infections in travellers according to purpose of travel and according to age and sex. Men and women have different infection susceptibilities but there is just one study on this theme in the context of travel medicine Infectious diseases, in particular the spread of malaria and "arboviral infections", i.e. viruses such as dengue, chikungunya and Zika pose major threats with changing areas of transmission influenced by climate and mobility. Although airline statistics are available on traveller numbers, the volume of ill, returning, possibly viremic travellers entering areas, where susceptible vectors exist has never been quantified. The situation of a twin presence of viremic travellers and competent Aedes vectors may lead to the onward transmission of arboviral infections. The ITIT project, evaluating in-travel and post-travel illness profiles, coupled with geo-location and meteorological data, will yield the granular data needed for personalized travel medicine. This is important given the heterogenicity and increasing volume of global travellers. The project has the support of the World Health Organization (WHO). Since the data will be collected anonymously via a questionnaire on the designed mobile App and the study is non-interventional, the risk category for this project is minimal (A).

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zürich, Switzerland, 8001
        • Epidemiology, Biostatistics and Prevention Institute at the University of Zurich
        • Contact:
        • Principal Investigator:
          • Patricia Schlagenhauf, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

International travellers who cross international borders and are traveling for varying purposes such as business/corporate travellers, those visiting friends and relatives (VFR), leisure/tourist travellers and mass gathering events (Hajj, Olympics, World Cup) attendees.

Description

Inclusion Criteria:

  1. travellers who cross international borders
  2. adults (over 18 years old)
  3. those traveling for more than 2 days and less than 8 weeks

Exclusion Criteria:

  1. Non travellers (not crossing international borders)
  2. Minors (under 18 years old)
  3. those traveling for less than 2 days and longer than 8 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arboviral infection or malaria positive cohort
No intervention is planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of travel-related infectious diseases
Time Frame: 8 weeks
The Likert scale, self-rating of severity is the unit used to evaluate infectious disease symptoms based on 4 health domains (gastrointestinal symptoms, respiratory symptoms, skin infections and rashes, fever, pain and myalgia) combined with the number of travellers reporting symptoms to get the incidence (travelers with illnesses per 100 travellers).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term sequelae of arboviral infections and malaria
Time Frame: 1 year
The quality-of-life scores and health survey SF-12 version scores will be combined to determine the difference in quality of life due to the infections studied.
1 year
change in epidemiology of travel-related infectious diseases
Time Frame: 1 year
Change in incidence of travel related infectious diseases over time (incidence change/time)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 30, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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