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)
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| ClinicalTrials.gov Identifier: NCT04672577 |
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Recruitment Status :
Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
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Sponsor:
Patricia Schlagenhauf
Collaborators:
ETH Zurich
Swiss Tropical & Public Health Institute
University Hospital, Geneva
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Information provided by (Responsible Party):
Patricia Schlagenhauf, University of Zurich
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Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Travel-Related Illness Malaria Dengue Chikungunya Zika SARS-CoV Infection MERS Influenza Diarrhea | Other: Observational study |
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 |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Infection Tracking in Travellers (ITIT) |
| Estimated Study Start Date : | January 30, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2025 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
| Arboviral infection or malaria positive cohort |
Other: Observational study
No intervention is planned |
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- 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.
- 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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
Inclusion Criteria:
- travellers who cross international borders
- adults (over 18 years old)
- those traveling for more than 2 days and less than 8 weeks
Exclusion Criteria:
- Non travellers (not crossing international borders)
- Minors (under 18 years old)
- those traveling for less than 2 days and longer than 8 weeks
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672577
Locations
| Switzerland | |
| Epidemiology, Biostatistics and Prevention Institute at the University of Zurich | |
| Zürich, Switzerland, 8001 | |
| Contact: Thibault Lovey thibault.lovey@uzh.ch | |
| Principal Investigator: Patricia Schlagenhauf, Prof. | |
Sponsors and Collaborators
Patricia Schlagenhauf
ETH Zurich
Swiss Tropical & Public Health Institute
University Hospital, Geneva
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Publications:
| Responsible Party: | Patricia Schlagenhauf, Prof. Dr., University of Zurich |
| ClinicalTrials.gov Identifier: | NCT04672577 |
| Other Study ID Numbers: |
ITIT |
| First Posted: | December 17, 2020 Key Record Dates |
| Last Update Posted: | December 17, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Infections Communicable Diseases Malaria Severe Acute Respiratory Syndrome Diarrhea Travel-Related Illness Disease Attributes Pathologic Processes Protozoan Infections Parasitic Diseases |
Vector Borne Diseases Signs and Symptoms, Digestive Virus Diseases RNA Virus Infections Respiratory Tract Infections Coronavirus Infections Coronaviridae Infections Nidovirales Infections Respiratory Tract Diseases |