- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04672577
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)
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Zürich, Switzerland, 8001
- Epidemiology, Biostatistics and Prevention Institute at the University of Zurich
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Contact:
- Thibault Lovey
- Email: thibault.lovey@uzh.ch
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Principal Investigator:
- Patricia Schlagenhauf, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arboviral infection or malaria positive cohort
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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
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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)
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1 year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Schlagenhauf P, Tschopp A, Johnson R, Nothdurft HD, Beck B, Schwartz E, Herold M, Krebs B, Veit O, Allwinn R, Steffen R. Tolerability of malaria chemoprophylaxis in non-immune travellers to sub-Saharan Africa: multicentre, randomised, double blind, four arm study. BMJ. 2003 Nov 8;327(7423):1078. doi: 10.1136/bmj.327.7423.1078.
- Farnham A, Blanke U, Stone E, Puhan MA, Hatz C. Travel medicine and mHealth technology: a study using smartphones to collect health data during travel. J Travel Med. 2016 Sep 4;23(6):taw056. doi: 10.1093/jtm/taw056. Print 2016 Jun.
- Findlater A, Moineddin R, Kain D, Yang J, Wang X, Lai S, Khan K, Bogoch II. The use of air travel data for predicting dengue importation to China: A modelling study. Travel Med Infect Dis. 2019 Sep-Oct;31:101446. doi: 10.1016/j.tmaid.2019.07.002. Epub 2019 Jul 5.
- Leta S, Beyene TJ, De Clercq EM, Amenu K, Kraemer MUG, Revie CW. Global risk mapping for major diseases transmitted by Aedes aegypti and Aedes albopictus. Int J Infect Dis. 2018 Feb;67:25-35. doi: 10.1016/j.ijid.2017.11.026. Epub 2017 Nov 28.
- Ponce C, Dolea C. The World Health Organisation (WHO) and International Travel and Health: New collaborative, evidence-based and digital directions. Travel Med Infect Dis. 2019 Jan-Feb;27:1. doi: 10.1016/j.tmaid.2019.01.012. Epub 2019 Jan 17. No abstract available.
- Schlagenhauf P, Chen LH, Wilson ME, Freedman DO, Tcheng D, Schwartz E, Pandey P, Weber R, Nadal D, Berger C, von Sonnenburg F, Keystone J, Leder K; GeoSentinel Surveillance Network. Sex and gender differences in travel-associated disease. Clin Infect Dis. 2010 Mar 15;50(6):826-32. doi: 10.1086/650575.
- Tomasello D, Schlagenhauf P. Chikungunya and dengue autochthonous cases in Europe, 2007-2012. Travel Med Infect Dis. 2013 Sep-Oct;11(5):274-84. doi: 10.1016/j.tmaid.2013.07.006. Epub 2013 Aug 17.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Disease Attributes
- Signs and Symptoms, Digestive
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Severe Acute Respiratory Syndrome
- Infections
- Communicable Diseases
- Diarrhea
- Malaria
- Travel-Related Illness
Other Study ID Numbers
- ITIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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