Use of Malaria Rapid Diagnostic Tests as a Decision Aid for the Management of Fever by International Travelers (JOKA-I)
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|ClinicalTrials.gov Identifier: NCT02900079|
Recruitment Status : Suspended (delays in obtaining study materials)
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 the incidence and 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. Its objective is to evaluate 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.
If the study demonstrates that malaria can be ruled out safely by travelers themselves using a RDT, a combination of self/peer testing with SBET may become an alternative to antimalarial chemoprophylaxis in travel medicine.
|Condition or disease||Intervention/treatment|
|Fever Malaria||Device: rapid diagnostic test for malaria antigen|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||4500 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||New Tools for Diagnosis and Management of Febrile Illness in Travelers to the Tropics: a Cohort Study- JOKA I|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
persons intending to travel for 3 weeks or longer to South-East Asia, Sub-Saharan Africa or South-/ Central America; they will be trained to use a rapid diagnostic test for malaria antigen when febrile. Upon a positive test result they are recommended to use standby emergency treatment (SBET)
Device: rapid diagnostic test for malaria antigen
rapid diagnostic test for malaria antigen to be used by travelers when febrile
- negative predictive value of a malaria RDT when used by travelers with febrile illness [ Time Frame: up to 12 weeks followup ]malaria RDT results will be compared to post hoc PCR diagnosis of malaria on the original test strip; the negative predictive value (NPV) will be calculated in a travelers' cohort. A NPV > 99,0 % will be considered as safe to rule out malaria.
- Qualitative description of ease of self-/peer- use of malaria RDT, measured by a self-reported questionnaire [ Time Frame: up to 12 weeks ]
- Time to treatment measured from time of obtaining test results by self-reporting [ Time Frame: up to 12 weeks ]Use of study diary
- Duration of symptoms by self-reporting [ Time Frame: up to 12 weeks ]Use of study diary
- Description of clinical symptoms and their frequencies by self-reporting [ Time Frame: up to 12 weeks ]Use of study diary
- self-reported management of illness in structured study diary [ Time Frame: up to 12 weeks ]self-treatment, consultation, hospitalization
- final clinical outcome of illness [ Time Frame: up to 12 weeks ]change of travel plans, repatriation, hospitalization, death as a result of illness during travel
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): NCT02900079
|Antwerp, Belgium, 2000|
|Study Chair:||Jan Jacobs, MD PhD||Institute of Tropical Medicine, Antwerp, Belgium|