FeverJOKA-INCT02900079
Use of Malaria Rapid Diagnostic Tests as a Decision Aid for the Management of Fever by International Travelers
An observational study of Fever and Malaria, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- rapid diagnostic test for malaria antigen
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2023to Mar 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: persons intending to travel to Asia, Africa, or America for a minimum duration of 3 weeks
Who may be able to join
- 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.
Who cannot join
- known intolerance or hypersensitivity to artemisinine based combination therapy
- known pregnancy at time of travel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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)
- 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.
- Being tested
- rapid diagnostic test for malaria antigen
- Keywords
- malaria, rapid diagnostic test, travel, fever, self care
- Medical subject headings
- Fever, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid diagnostic test for malaria antigenDevice
rapid diagnostic test for malaria antigen to be used by travelers when febrile
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: rapid diagnostic test for malaria antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 12 weeks
Time to treatment measured from time of obtaining test results by self-reporting
Use of study diary
Measured: up to 12 weeks
Duration of symptoms by self-reporting
Use of study diary
Measured: up to 12 weeks
Description of clinical symptoms and their frequencies by self-reporting
Use of study diary
Measured: up to 12 weeks
self-reported management of illness in structured study diary
self-treatment, consultation, hospitalization
Measured: up to 12 weeks
final clinical outcome of illness
change of travel plans, repatriation, hospitalization, death as a result of illness during travel
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start1 Jul 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: delays in obtaining study materials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Jacobs, MD PhD, Study chair, Institute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900079
- Sponsor's protocol ID
- B300201627244
- Acronym
- JOKA-I
- Status last verified
- Sep 2023
- First submitted
- 16 Mar 2016
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11803507Checkley 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.
PubMed 22454091Seringe 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.
PubMed 21529388Landry 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.
PubMed 16412104Senn 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.
PubMed 18165513Hatz 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.
PubMed 18256423Visser 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.
PubMed 25428624Voumard 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.
PubMed 25889529Schlagenhauf 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.
PubMed 22702318Jelinek 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.
PubMed 10560678Maltha 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.
PubMed 23301027Maltha 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.
PubMed 23373854
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Tools for Diagnosis and Management of Febrile Illness in Travelers to the Tropics: a Cohort Study- JOKA I
- ClinicalTrials.gov ID
- NCT02900079
- Acronym / sponsor ID
- JOKA-I / B300201627244
- Keywords
- malaria, rapid diagnostic test, travel, fever, self care
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: delays in obtaining study materials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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)
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| travelers | – | Device: rapid diagnostic test for malaria antigenpersons 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- persons intending to travel to Asia, Africa, or America for a minimum duration of 3 weeks
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- known intolerance or hypersensitivity to artemisinine based combination therapy
- known pregnancy at time of travel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid diagnostic test for malaria antigenrapid diagnostic test for malaria antigen to be used by travelers when febrile | Device | travelers |
Primary outcome
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.
6 secondary outcomes
Qualitative description of ease of self-/peer- use of malaria RDT, measured by a self-reported questionnaire
Time frame: up to 12 weeks
Time to treatment measured from time of obtaining test results by self-reporting
Time frame: up to 12 weeks
Duration of symptoms by self-reporting
Time frame: up to 12 weeks
Description of clinical symptoms and their frequencies by self-reporting
Time frame: up to 12 weeks
self-reported management of illness in structured study diary
Time frame: up to 12 weeks
final clinical outcome of illness
Time frame: up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 11803507Jelinek 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.
- Background: PubMed 22454091Checkley 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.
- Background: PubMed 21529388Seringe 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.
- Background: PubMed 16412104Landry 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.
- Background: PubMed 18165513Senn 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.
- Background: PubMed 18256423Hatz 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.
- Background: PubMed 25428624Visser 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.
- Background: PubMed 25889529Voumard 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.
- Background: PubMed 22702318Schlagenhauf 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.
- Background: PubMed 10560678Jelinek 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.
- Background: PubMed 23301027Maltha 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.
- Background: PubMed 23373854Maltha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jacobs, MD PhD study chair
Institute of Tropical Medicine, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Malaria, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative predictive value of a malaria RDT when used by travelers with febrile illness (time frame: up to 12 weeks followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02900079, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.