Use of Malaria Rapid Diagnostic Tests as a Decision Aid for the Management of Fever by International Travelers (JOKA-I)

September 27, 2023 updated by: Institute of Tropical Medicine, Belgium

New Tools for Diagnosis and Management of Febrile Illness in Travelers to the Tropics: a Cohort Study- JOKA I

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Objectives:

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.

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 ("Erkend Centrum voor Medisch Reisadvies en Inentingen") 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).
  • Collection and recording of demographic, clinical and travel data.
  • Sampling of a baseline serum sample (for paired pre- and post-travel diagnostic analysis).
  • Training of travelers, peers and travel guides to perform and interpret a malaria RDT (training is a prerequisite for study participation).

  • Provision of study materials (study diary/apps, malaria kits, thermometer, …) and written instructions for use during travel if fever occurs.

    2. During travel

  • In case of any illness (associated with fever or not), the traveler will record symptoms in the study diary.
  • If fever is documented (axillary temperature ≥ 37.8°C - or in case a thermometer is not immediately available, fever sensation in association with sweats or chills)- blood from a finger prick will be collected for use of the malaria rapid diagnostic test (RDT, presenting as a nitrocellulose strip in a plastic cassette).
  • In case of a positive RDT result the traveler is advised to start artemisinin based combination therapy (ACT) as 'standby emergency treatment' (SBET) for malaria as soon as possible.
  • All febrile travelers are advised to seek medical attendance as they would do when not participating in the study.
  • To guide interpretation of the RDT test results, precise instructions will be provided (Annex); to allow post-hoc verification, photographs of the RDT test will be taken at the time of reading, to be kept or sent to the ITM study team for advice (see below)quality control and study documentation. Participants will also asked to store the RDT cassette for further analysis upon return.
  • The final decision to use standby emergency treatment malaria treatment (SBET) is made by the study participant, in accordance with precise and written instructions.
  • The study team (Tropical medicine experts at ITM) will be available for teleconsultation by Email or Telephone, and will provide medical advice (including assistance in RDT reading and interpretation) within 12 hours. Note: contacting the ITM study team is an option, but should not cause delay in treating suspected malaria.

  • Study participants will collect all relevant data related to the (outcome of the) illness episode (duration of symptoms, consultation of a health practitioner, admission/duration of stay in a hospital, treatment received and timing, repatriation)

    3. Post-travel consultation will be scheduled for all study participants who experience(d) any illness (febrile or not) within a week after travel- sooner if the medical condition requires so- and for those who have no complaints but do seek post-travel health evaluation.

  • A structured clinical evaluation will be performed by an expert in travel medicine and will be recorded in the database. Laboratory evaluation will include hematological, biochemical and microbiological/parasitological analysis

  • Used RDTs will be collected for confirmation of the test result by Polymerase Chain Reaction (PCR).

    • Data analysis : All data (demographic, geographic, clinical, laboratory and final diagnosis) will be recorded in an encoded database. Descriptive and inferential statistics as appropriate, STATA 14.
    • Sample size: n= 350 fever cases; at an incidence of fever of 8% a cohort of 4400 (healthy) travelers will be recruited over 30 months (Feb 2016 - Aug 2018).
    • Endpoints:
  • To determine the post-test probability for malaria after a negative RDT result (i.e. excluding power of the RDT) as well as other measures of diagnostic accuracy (sensitivity, specificity, positive predictive value) in travelers with febrile illness, when performed by travelers (or their peers)- compared with PCR detection of Plasmodium spp. on the RDT after return
  • Qualitative description of ease of self-/peer- use of malaria RDT
  • Incidence rates for malaria (by use of RDT and post-travel PCR on RDT)
  • Clinical course and outcomes of (self-)management of febrile illness during travel.

Expected results and relevance:

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • ITM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks followup

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative description of ease of self-/peer- use of malaria RDT, measured by a self-reported questionnaire
Time Frame: up to 12 weeks
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
up to 12 weeks
Duration of symptoms by self-reporting
Time Frame: up to 12 weeks
Use of study diary
up to 12 weeks
Description of clinical symptoms and their frequencies by self-reporting
Time Frame: up to 12 weeks
Use of study diary
up to 12 weeks
self-reported management of illness in structured study diary
Time Frame: up to 12 weeks
self-treatment, consultation, hospitalization
up to 12 weeks
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
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Tropical Medicine, Belgium

Investigators

  • Study Chair: Jan Jacobs, MD PhD, Institute of Tropical Medicine, Antwerp, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimated)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201627244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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