Clinical Trial: Filter Paper Blood Spots Collected During Fever as a Source for Post-travel Diagnosis in Travelers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Filter Paper Blood Spots Collected During Fever as a Source for Post-travel Diagnosis of Arboviral and Rickettsial Infections in a Cohort of Travelers

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 Summary:

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)

1. Pre-travel consultation at a certified travel clinic will systematically be recommended; this consultation will include:

  1. routine travel advice directed at travel destination, (including vaccinations and prescription for anti-malarial chemoprophylaxis according to current recommendations, details of which are published at www.reisgeneeskunde.be and

  2. the following research-related activities.

    • Briefing sessions on the topic "Fever in The Tropics" by an ITM physician (during this session the differences between fever at home and in the tropics will be addressed and the importance of consulting a local doctor will be stressed).
    • PCR analysis will be directed by antibody detection in paired sera, and post-travel clinical evaluation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical outcome of febrile illness during travel [ Time Frame: up to 6 months of follow-up per individual traveler ]
    Final clinical outcome per diagnosis (change of travel plans, repatriation, hospitalization as a result of illness during travel, death).
  • incidence of etiological diagnoses of fever expressed as risk per person- year of travel per region traveled [ Time Frame: up to 6 months of follow-up per individual traveler ]
  • Time from start of travel to development of fever by self-reporting [ Time Frame: up to 6 months of follow-up per individual traveler ]
  • duration of symptoms by self-reporting in a structured study diary [ Time Frame: up to 6 months of follow-up per individual traveler ]
  • Type of treatment per diagnosis reported in a structured study diary [ Time Frame: up to 6 months of follow-up per individual traveler ]
    symptomatic/ empiric/ targeted upon diagnosis abroad


Original Secondary Outcome: Same as current

Information By: Institute of Tropical Medicine, Belgium

Dates:
Date Received: March 16, 2016
Date Started: February 2016
Date Completion: August 2018
Last Updated: September 8, 2016
Last Verified: September 2016