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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
Sponsor:
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Malaria

Group/Cohort Intervention/treatment
travelers
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Qualitative description of ease of self-/peer- use of malaria RDT, measured by a self-reported questionnaire [ Time Frame: up to 12 weeks ]
  2. Time to treatment measured from time of obtaining test results by self-reporting [ Time Frame: up to 12 weeks ]
    Use of study diary

  3. Duration of symptoms by self-reporting [ Time Frame: up to 12 weeks ]
    Use of study diary

  4. Description of clinical symptoms and their frequencies by self-reporting [ Time Frame: up to 12 weeks ]
    Use of study diary

  5. self-reported management of illness in structured study diary [ Time Frame: up to 12 weeks ]
    self-treatment, consultation, hospitalization

  6. 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
sera, capillary blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
persons intending to travel to Asia, Africa, or America for a minimum duration of 3 weeks
Criteria

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 use RDT
  • Willing and able to provide written informed consent
  • Adults fulfilling all criteria and volunteer to have their RDT collected by their trained peers during travel, may be included for analysis after obtaining informed consent upon post-travel evaluation.

Exclusion Criteria:

  • known intolerance or hypersensitivity to artemisinine based combination therapy
  • known pregnancy at time of travel

Information from the National Library of Medicine

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


Locations
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Belgium
ITM
Antwerp, Belgium, 2000
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Investigators
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Study Chair: Jan Jacobs, MD PhD Institute of Tropical Medicine, Antwerp, Belgium

Additional Information:

Publications:

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02900079     History of Changes
Other Study ID Numbers: B300201627244
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institute of Tropical Medicine, Belgium:
malaria
rapid diagnostic test
travel
fever
self care
Additional relevant MeSH terms:
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Malaria
Fever
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms