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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
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 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
Fever

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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 ]
  3. Time from start of travel to development of fever by self-reporting [ Time Frame: up to 6 months of follow-up per individual traveler ]
  4. duration of symptoms by self-reporting in a structured study diary [ Time Frame: up to 6 months of follow-up per individual traveler ]
  5. 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
sera, capillary blood


Information from the National Library of Medicine

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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 collect BFP OR
    • Travel with anyone who has been trained
  • Willing and able to provide written informed consent.
  • Adults fulfilling all criteria and volunteer to have their BFP collected by their trained peers during travel, may be included for analysis after obtaining informed consent upon post-travel evaluation.

Exclusion criteria:

  • Unable to comply with study protocol.

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): NCT02900066


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:

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02900066     History of Changes
Other Study ID Numbers: B-300201627244
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:
fever
traveler
arbovirus
rickettsia
malaria
filter paper
diagnosis
Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms