Filter Paper Blood Spots Collected During Fever as a Source for Post-travel Diagnosis in Travelers (JOKA-II)
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|ClinicalTrials.gov Identifier: NCT02900066|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : April 12, 2018
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||350 participants|
|Target Follow-Up Duration:||6 Months|
|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|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
- 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
- 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
Biospecimen Retention: Samples Without DNA
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): NCT02900066
|Antwerp, Belgium, 2000|
|Study Chair:||Jan Jacobs, MD PhD||Institute of Tropical Medicine, Antwerp, Belgium|