Filter Paper Blood Spots Collected During Fever as a Source for Post-travel Diagnosis of Arboviral and Rickettsial Infections in a Cohort of Travelers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Incidence of etiological diagnoses in febrile travelers as assessed by post hoc clinical evaluation
Study Overview
Brief Summary
This study is part of a larger prospective cohort study (JOKA), designed to study febrile illness occurring during a travel to the tropics, as well as the evaluation of the clinical use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a decision aid for the management of febrile illness in the tropics.
Filter paper blood spots and paired serology are used in addition to routine post-travel evaluation, to study the incidence and etiological spectrum of febrile illness occurring during travel to the tropics.
The study will yield valuable and prospective data of incidence rate, the clinical and etiological spectrum, clinical course and outcome of febrile illness during (and post-)travel in a prospective cohorts of travelers. This knowledge may lead to better pre-travel advice.
Detailed Description
Objectives:
To study the incidence etiological spectrum of febrile illness occurring during a travel to the tropics, as well as clinical course, care, treatment and outcome of these febrile illness episodes.
Design: Prospective cohort study of febrile illness in international travelers Population: Travelers who are going to destinations in the tropics (South-East Asia (SEA), Sub-Saharan Africa (SSA) and South America (SCA)) for 3 weeks or longer will be invited to participate and, after obtaining informed consent, recruited in the study protocol(s) at the time of planning departure (directly at the ITM or through travel/ humanitarian relief organizations).
Methods:
Participants will be offered pre-, per- and post-travel consultation as explained below (Inclusion through ITM)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Residing in Belgium.
- •Attend a briefing session on the topic "Fever in The Tropics" by an ITM physician.
- •Able to comply with study procedures:
- •Carry and complete a study diary in case of illness
- •Be trained to collect BFP OR
- •Travel with anyone who has been trained
- •Willing and able to provide written informed consent.
- •Adults fulfilling all criteria and volunteer to have their BFP collected by their trained peers during travel, may be included for analysis after obtaining informed consent upon post-travel evaluation.
- •Exclusion criteria:
- •Unable to comply with study protocol.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of etiological diagnoses in febrile travelers as assessed by post hoc clinical evaluation
Time Frame: up to 6 months of follow-up per individual traveler
PCR analysis will be directed by antibody detection in paired sera, and post-travel clinical evaluation
Secondary Outcomes
- Clinical outcome of febrile illness during travel(up to 6 months of follow-up per individual traveler)
- Time from start of travel to development of fever by self-reporting(up to 6 months of follow-up per individual traveler)
- incidence of etiological diagnoses of fever expressed as risk per person- year of travel per region traveled(up to 6 months of follow-up per individual traveler)
- duration of symptoms by self-reporting in a structured study diary(up to 6 months of follow-up per individual traveler)
- Type of treatment per diagnosis reported in a structured study diary(up to 6 months of follow-up per individual traveler)