Filter Paper Blood Spots Collected During Fever as a Source for Post-travel Diagnosis in Travelers

NCT02900066 | Completed DMC

• 1 other identifier: B-300201627244
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever

Keywords

fever; traveler; arbovirus; rickettsia; malaria; filter paper; diagnosis

Outcome Measures

Primary Outcomes (1)

• Incidence of etiological diagnoses in febrile travelers as assessed by post hoc clinical evaluation

  PCR analysis will be directed by antibody detection in paired sera, and post-travel clinical evaluation

  up to 6 months of follow-up per individual traveler

Secondary Outcomes (5)

• Clinical outcome of febrile illness during travel

  up to 6 months of follow-up per individual traveler

• incidence of etiological diagnoses of fever expressed as risk per person- year of travel per region traveled

  up to 6 months of follow-up per individual traveler

• Time from start of travel to development of fever by self-reporting

  up to 6 months of follow-up per individual traveler

• duration of symptoms by self-reporting in a structured study diary

  up to 6 months of follow-up per individual traveler

• Type of treatment per diagnosis reported in a structured study diary

  up to 6 months of follow-up per individual traveler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persons intending to travel to Asia, Africa, or America for a minimum duration of 3 weeks

You may qualify if:

• 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.

You may not qualify if:

• Unable to comply with study protocol.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

ITM

Antwerp, 2000, Belgium

Location

Related Publications (1)

• Huits R, Van Den Bossche D, Eggermont K, Lotgering E, Feyens AM, Potters I, Jacobs J, Van Esbroeck M, Cnops L, Bottieau E. Incidence of Zika virus infection in a prospective cohort of Belgian travellers to the Americas in 2016. Int J Infect Dis. 2019 Jan;78:39-43. doi: 10.1016/j.ijid.2018.10.010. Epub 2018 Oct 24.

  PMID: 30368020 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera, capillary blood

MeSH Terms

Conditions

Fever; Malaria; Disease

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes

Study Officials

• Jan Jacobs, MD PhD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: September 14, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)