Use of Malaria Rapid Diagnostic Tests as a Decision Aid for the Management of Fever by International Travelers

NCT02900079 | Withdrawn DMC

• 1 other identifier: B300201627244
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever; Malaria

Keywords

malaria; rapid diagnostic test; travel; fever; self care

Outcome Measures

Primary Outcomes (1)

• negative predictive value of a malaria RDT when used by travelers with febrile illness

  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 Outcomes (6)

• Qualitative description of ease of self-/peer- use of malaria RDT, measured by a self-reported questionnaire

  up to 12 weeks

• Time to treatment measured from time of obtaining test results by self-reporting

  up to 12 weeks

• Duration of symptoms by self-reporting

  up to 12 weeks

• Description of clinical symptoms and their frequencies by self-reporting

  up to 12 weeks

• self-reported management of illness in structured study diary

  up to 12 weeks

Study Arms (1)

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

Interventions

rapid diagnostic test for malaria antigen DEVICE

rapid diagnostic test for malaria antigen to be used by travelers when febrile

travelers

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 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

ITM

Antwerp, 2000, Belgium

Location

Related Publications (12)

• Jelinek T, Schulte C, Behrens R, Grobusch MP, Coulaud JP, Bisoffi Z, Matteelli A, Clerinx J, Corachan M, Puente S, Gjorup I, Harms G, Kollaritsch H, Kotlowski A, Bjorkmann A, Delmont JP, Knobloch J, Nielsen LN, Cuadros J, Hatz C, Beran J, Schmid ML, Schulze M, Lopez-Velez R, Fleischer K, Kapaun A, McWhinney P, Kern P, Atougia J, Fry G, da Cunha S, Boecken G. Imported Falciparum malaria in Europe: sentinel surveillance data from the European network on surveillance of imported infectious diseases. Clin Infect Dis. 2002 Mar 1;34(5):572-6. doi: 10.1086/338235. Epub 2002 Jan 21.

  PMID: 11803507 BACKGROUND

• Checkley AM, Smith A, Smith V, Blaze M, Bradley D, Chiodini PL, Whitty CJ. Risk factors for mortality from imported falciparum malaria in the United Kingdom over 20 years: an observational study. BMJ. 2012 Mar 27;344:e2116. doi: 10.1136/bmj.e2116.

  PMID: 22454091 BACKGROUND

• Seringe E, Thellier M, Fontanet A, Legros F, Bouchaud O, Ancelle T, Kendjo E, Houze S, Le Bras J, Danis M, Durand R; French National Reference Center for Imported Malaria Study Group. Severe imported Plasmodium falciparum malaria, France, 1996-2003. Emerg Infect Dis. 2011 May;17(5):807-13. doi: 10.3201/eid1705.101527.

  PMID: 21529388 BACKGROUND

• Landry P, Iorillo D, Darioli R, Burnier M, Genton B. Do travelers really take their mefloquine malaria chemoprophylaxis? Estimation of adherence by an electronic pillbox. J Travel Med. 2006 Jan-Feb;13(1):8-14. doi: 10.1111/j.1708-8305.2006.00005.x.

  PMID: 16412104 BACKGROUND

• Senn N, D'Acremont V, Landry P, Genton B. Malaria chemoprophylaxis: what do the travelers choose, and how does pretravel consultation influence their final decision. Am J Trop Med Hyg. 2007 Dec;77(6):1010-4.

  PMID: 18165513 BACKGROUND

• Hatz C, Soto J, Nothdurft HD, Zoller T, Weitzel T, Loutan L, Bricaire F, Gay F, Burchard GD, Andriano K, Lefevre G, De Palacios PI, Genton B. Treatment of acute uncomplicated falciparum malaria with artemether-lumefantrine in nonimmune populations: a safety, efficacy, and pharmacokinetic study. Am J Trop Med Hyg. 2008 Feb;78(2):241-7.

  PMID: 18256423 BACKGROUND

• Visser BJ, Wieten RW, Kroon D, Nagel IM, Belard S, van Vugt M, Grobusch MP. Efficacy and safety of artemisinin combination therapy (ACT) for non-falciparum malaria: a systematic review. Malar J. 2014 Nov 26;13:463. doi: 10.1186/1475-2875-13-463.

  PMID: 25428624 BACKGROUND

• Voumard R, Berthod D, Rambaud-Althaus C, D'Acremont V, Genton B. Recommendations for malaria prevention in moderate to low risk areas: travellers' choice and risk perception. Malar J. 2015 Apr 1;14:139. doi: 10.1186/s12936-015-0654-y.

  PMID: 25889529 BACKGROUND

• Schlagenhauf P, Petersen E. Standby emergency treatment of malaria in travelers: experience to date and new developments. Expert Rev Anti Infect Ther. 2012 May;10(5):537-46. doi: 10.1586/eri.12.42.

  PMID: 22702318 BACKGROUND

• Jelinek T, Amsler L, Grobusch MP, Nothdurft HD. Self-use of rapid tests for malaria diagnosis by tourists. Lancet. 1999 Nov 6;354(9190):1609. doi: 10.1016/s0140-6736(99)01969-8.

  PMID: 10560678 BACKGROUND

• Maltha J, Gillet P, Heutmekers M, Bottieau E, Van Gompel A, Jacobs J. Self-diagnosis of malaria by travelers and expatriates: assessment of malaria rapid diagnostic tests available on the internet. PLoS One. 2013;8(1):e53102. doi: 10.1371/journal.pone.0053102. Epub 2013 Jan 2.

  PMID: 23301027 BACKGROUND

• Maltha J, Gillet P, Jacobs J. Malaria rapid diagnostic tests in travel medicine. Clin Microbiol Infect. 2013 May;19(5):408-15. doi: 10.1111/1469-0691.12152. Epub 2013 Feb 1.

  PMID: 23373854 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera, capillary blood

MeSH Terms

Conditions

Fever; Malaria

Interventions

Rapid Diagnostic Tests

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

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: July 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)