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African TrypanosomiasesDiTECT-WP2NCT03356665

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection

A study testing Rapid diagnostic test (RDT) and Serological and molecular tests on DBS in people with African Trypanosomiases and West African; Trypanosomiasis, run by Institut de Recherche pour le Developpement at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on human African trypanosomiasis clinical suspects in peripheral health centres, whether or not followed by serological and/or molecular tests on dried blood spots done at regional reference centres Read more about this study

Who is it for?
Ages 4 years and older
What is being tested?
Rapid diagnostic test (RDT) and Serological and molecular tests on DBS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,700 participants
Where
3 sitesin 3 countries
Study dates
1 Aug 2017to 31 Jan 2021
Phase
Interventional
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 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Visit of or residence in a HAT endemic area
  • Clinical suspicion of HAT based on: Recurrent fever not responding to anti-malarial medication; or Headache for a long duration (>14 days); or presence of swollen lymph nodes in the neck; or Important weight loss; or Weakness; or Important scratching; or Amenorrhea, abortion(s), or sterility; or Coma; or Psychiatric problems (aggressiveness, apathy, mental confusion, increasing unusual hilarity, ...); or Sleep disruption (nocturnal insomnia and excessive diurnal sleeping); or Motor abnormalities (convulsions, abnormal movements, shaking, walking difficulties); or Speech disorders.

Who cannot join

  • Previously treated for HAT (irrespective of time elapsed since treatment)
  • No informed consent
  • < 4 years old

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Côte d’Ivoire1 site

  • Institut Pierre Richet, Institut National de Santé Publique

    Bouaké

Other trials in Côte d’Ivoire

Democratic Republic of the Congo1 site

  • Programme Nationale de Lutte contre la trypanosomiase humaine Africaine

    Kinshasa

Other trials in Democratic Republic of the Congo

Guinea1 site

  • Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie

    Conakry

Other trials in Guinea

About this study

The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on human African trypanosomiasis clinical suspects in peripheral health centres, whether or not followed by serological and/or molecular tests on dried blood spots done at regional reference centres

Read the detailed description

In the last decade, the prevalence of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) has fallen and HAT has been targeted for elimination. At low disease prevalence, integration of case finding into routine activities of peripheral health centres becomes crucial. However, HAT case detection by the peripheral health system with limited resources requires adapted diagnostic tests and test algorithms.

The objective of the DiTECT-HAT-WP2 study is to determine the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on clinical suspects in peripheral health centres, whether or not followed by serological and/or molecular tests on filter paper done at regional reference centres.

The DiTECT-HAT-WP2 study will be conducted in centres for diagnosis and treatment and in sites for serological screening in Guinea, Côte d'Ivoire and DR Congo. In these centres and sites, clinical suspects will be tested with several commercially available RDTs for HAT. Clinical suspects with at least 1 RDT positive result, will 1° undergo parasitological examination and 2° blood collection on filter paper for reference analysis in trypanolysis, LAMP, ELISA and real-time PCR in the regional reference laboratory. If the reference laboratory tests and parasitological examinations are all negative, the suspect is informed and considered free of HAT. If at least 1 reference test is positive, parasitological examinations are repeated at least twice at three months interval, unless trypanosomes are detected. In order to assess the sensitivity, specificity, Positive Predictive Values and Negative Predictive Values of each assay in these multiple populations, the data from the multiple assays in the 3 countries will be used in a Bayesian formulation of the Hui-Walter latent class model, to estimate the assay performances in the absence of a gold standard. As we will collect full cost information for the different algorithms, we will, in addition to estimating the diagnostic effectiveness of the assay, be able to estimate the cost of each assay in each setting, and rank this jointly with assay performance.

The results will enable us to propose cost-effective test algorithms to detect HAT, adapted to peripheral health centres. Algorithms with high positive predictive values might allow test-and-treat scenarios without the need for complicated parasitological confirmations, once safe oral easy to use drugs become available to treat HAT.

Being tested
Rapid diagnostic test (RDT), Serological and molecular tests on DBS
Keywords
diagnosis, sensitivity, specificity, rapid diagnostic test, molecular biology, LAMP, RT-PCR, serology, ELISA, immune trypanolysis, clinical symptom
Medical subject headings
Trypanosomiasis, African, Trypanosomiasis, Infections, Disease, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rapid diagnostic test (RDT)Diagnostic test

    Also called rHAT Sero-Strip (Coris Bioconcept, Belgium), SD Bioline HAT 1.0 (Standard Diagnostics Korea), HAT Sero-K-Set (Coris Bioconcept, Belgium), SD Bioline HAT 2.0 (Standard Diagnostics Korea)

    The 4 rapid diagnostic tests (RDT) will be carried out on fresh blood from clinical suspects. Only those subjects that are positive in at least 1 RDT will 1) undergo tests on DBS (immune trypanolysis, ELISA and DNA detection); 2) undergo parasitological confirmation (reference standard) at inclusion.

  • Serological and molecular tests on DBSDiagnostic test

    Also called Immune trypanolysis: presence of antibodies, ELISA: on native LiTat 1.3 + LiTat 1.5 VSG, Loopamp T. brucei Detection Kit (Eiken), RT-PCR: Trypanozoon 18S, Tbg TgsGP

    Serological and molecular reference tests on dried blood spots (DBS) are carried out on RDT positive clinical suspects, which also undergo parasitological examination at inclusion (reference standard). If at least one of the serological or molecular reference tests on dried blood spots is positive, parasitological examination is repeated 3 and 6 months after inclusion. The combined results of parasitological examinations (at inclusion and if applicable at 3 and 6 months) serve as reference standard

Study groups in NCT03356665
Study groupRoleWhat they receive
Clinical suspectExperimentalDiagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS
Receives: Diagnostic Test: Rapid diagnostic test (RDT); Diagnostic Test: Serological and molecular tests on DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on HAT clinical suspects

    Index tests: 4 RDTs on fresh blood, and for RDT positives also immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS.

    Reference standard: for RDT positives only: combined results of parasitological examination at inclusion and if one of tests on DBS positive, at 3 and 6 months. Subjects negative in all RDTs are considered HAT negative

    Measured: 6 months

  2. Specificity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on HAT clinical suspects

    Index tests: 4 RDTs on fresh blood, and for RDT positives also immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS.

    Reference standard: for RDT positives only: combined results of parasitological examination at inclusion and if one of tests on DBS positive, at 3 and 6 months. Subjects negative in all RDTs are considered HAT negative.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study start1 Aug 2017
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Sequential assignement
Masking
None (open label)
Enrolment
10,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356665
Sponsor's protocol ID
DiTECT-HAT-WP2
Acronym
DiTECT-WP2
Status last verified
Feb 2021
First submitted
24 Nov 2017
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bisser S, Lumbala C, Nguertoum E, Kande V, Flevaud L, Vatunga G, Boelaert M, Buscher P, Josenando T, Bessell PR, Bieler S, Ndung'u JM. Sensitivity and Specificity of a Prototype Rapid Diagnostic Test for the Detection of Trypanosoma brucei gambiense Infection: A Multi-centric Prospective Study. PLoS Negl Trop Dis. 2016 Apr 8;10(4):e0004608. doi: 10.1371/journal.pntd.0004608. eCollection 2016 Apr.

    PubMed 27058033

  • Buscher P, Deborggraeve S. How can molecular diagnostics contribute to the elimination of human African trypanosomiasis? Expert Rev Mol Diagn. 2015 May;15(5):607-15. doi: 10.1586/14737159.2015.1027195. Epub 2015 Mar 18.

    PubMed 25786994

  • Buscher P, Mertens P, Leclipteux T, Gilleman Q, Jacquet D, Mumba-Ngoyi D, Pyana PP, Boelaert M, Lejon V. Sensitivity and specificity of HAT Sero-K-SeT, a rapid diagnostic test for serodiagnosis of sleeping sickness caused by Trypanosoma brucei gambiense: a case-control study. Lancet Glob Health. 2014 Jun;2(6):e359-63. doi: 10.1016/S2214-109X(14)70203-7. Epub 2014 May 9.

    PubMed 25103304

  • Camara O, Camara M, Lejon V, Ilboudo H, Sakande H, Leno M, Buscher P, Bucheton B, Jamonneau V. Immune trypanolysis test with blood spotted on filter paper for epidemiological surveillance of sleeping sickness. Trop Med Int Health. 2014 Jul;19(7):828-31. doi: 10.1111/tmi.12316. Epub 2014 Apr 18.

    PubMed 24750463

  • Hasker E, Lutumba P, Mumba D, Lejon V, Buscher P, Kande V, Muyembe JJ, Menten J, Robays J, Boelaert M. Diagnostic accuracy and feasibility of serological tests on filter paper samples for outbreak detection of T.b. gambiense human African trypanosomiasis. Am J Trop Med Hyg. 2010 Aug;83(2):374-9. doi: 10.4269/ajtmh.2010.09-0735.

    PubMed 20682885

  • Jamonneau V, Bucheton B, Kabore J, Ilboudo H, Camara O, Courtin F, Solano P, Kaba D, Kambire R, Lingue K, Camara M, Baelmans R, Lejon V, Buscher P. Revisiting the immune trypanolysis test to optimise epidemiological surveillance and control of sleeping sickness in West Africa. PLoS Negl Trop Dis. 2010 Dec 21;4(12):e917. doi: 10.1371/journal.pntd.0000917.

    PubMed 21200417

  • Jamonneau V, Camara O, Ilboudo H, Peylhard M, Koffi M, Sakande H, N'Dri L, Sanou D, Dama E, Camara M, Lejon V. Accuracy of individual rapid tests for serodiagnosis of gambiense sleeping sickness in West Africa. PLoS Negl Trop Dis. 2015 Feb 2;9(2):e0003480. doi: 10.1371/journal.pntd.0003480. eCollection 2015 Feb.

    PubMed 25642701

  • Mitashi P, Hasker E, Mbo F, Van Geertruyden JP, Kaswa M, Lumbala C, Boelaert M, Lutumba P. Integration of diagnosis and treatment of sleeping sickness in primary healthcare facilities in the Democratic Republic of the Congo. Trop Med Int Health. 2015 Jan;20(1):98-105. doi: 10.1111/tmi.12404. Epub 2014 Oct 20.

    PubMed 25329353

  • Mitashi P, Hasker E, Ngoyi DM, Pyana PP, Lejon V, Van der Veken W, Lutumba P, Buscher P, Boelaert M, Deborggraeve S. Diagnostic accuracy of loopamp Trypanosoma brucei detection kit for diagnosis of human African trypanosomiasis in clinical samples. PLoS Negl Trop Dis. 2013 Oct 17;7(10):e2504. doi: 10.1371/journal.pntd.0002504. eCollection 2013.

    PubMed 24147176

  • Mumba D, Bohorquez E, Messina J, Kande V, Taylor SM, Tshefu AK, Muwonga J, Kashamuka MM, Emch M, Tidwell R, Buscher P, Meshnick SR. Prevalence of human African trypanosomiasis in the Democratic Republic of the Congo. PLoS Negl Trop Dis. 2011 Aug;5(8):e1246. doi: 10.1371/journal.pntd.0001246. Epub 2011 Aug 2.

    PubMed 21829736

  • Njiru ZK. Loop-mediated isothermal amplification technology: towards point of care diagnostics. PLoS Negl Trop Dis. 2012;6(6):e1572. doi: 10.1371/journal.pntd.0001572. Epub 2012 Jun 26. No abstract available.

    PubMed 22745836

  • Van Meirvenne N, Magnus E, Buscher P. Evaluation of variant specific trypanolysis tests for serodiagnosis of human infections with Trypanosoma brucei gambiense. Acta Trop. 1995 Dec;60(3):189-99. doi: 10.1016/0001-706x(95)00127-z.

    PubMed 8907397

  • Makabuza J, Lukusa IN, Lumbala C, Miaka EM, Nganzobo P, Fukinsia A, Kwete J, Bebronne N, Buscher P, Ngoyi DM, Lejon V. Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation and prospective evaluation of rapid diagnostic and reference laboratory test accuracy. PLoS Negl Trop Dis. 2025 Sep 29;19(9):e0013045. doi: 10.1371/journal.pntd.0013045. eCollection 2025 Sep.

    PubMed 41021650

  • Camara O, Camara M, Falzon LC, Ilboudo H, Kabore J, Compaore CFA, Fevre EM, Buscher P, Bucheton B, Lejon V. Performance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human African trypanosomiasis by passive screening in Guinea: a prospective diagnostic accuracy study. Infect Dis Poverty. 2023 Mar 20;12(1):22. doi: 10.1186/s40249-023-01076-1.

    PubMed 36941656

  • Kone M, Kaba D, Kabore J, Thomas LF, Falzon LC, Koffi M, Kouame CM, Ahouty B, Compaore CFA, N'Gouan EK, Solano P, Fevre E, Buscher P, Lejon V, Jamonneau V. Passive surveillance of human African trypanosomiasis in Cote d'Ivoire: Understanding prevalence, clinical symptoms and signs, and diagnostic test characteristics. PLoS Negl Trop Dis. 2021 Aug 30;15(8):e0009656. doi: 10.1371/journal.pntd.0009656. eCollection 2021 Aug.

    PubMed 34460829

Questions about this trial

What is this clinical trial studying?

A study testing Rapid diagnostic test (RDT) and Serological and molecular tests on DBS in people with African Trypanosomiases and West African; Trypanosomiasis, run by Institut de Recherche pour le Developpement at 3 sites in 3 countries.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Côte d’Ivoire, Democratic Republic of the Congo, Guinea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sensitivity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on HAT clinical suspects (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03356665, which also lists 15 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 21 Feb 2021.

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