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

NCT03356665 | Completed

• 1 other identifier: DiTECT-HAT-WP2
• Study Type: interventional
• Target: 10,700
• Locations: 3 countries
• Sites: 3

Brief 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

Conditions

African Trypanosomiases; West African; Trypanosomiasis; Sleeping Sickness; West African; Trypanosoma Brucei Gambiense; Infection

Keywords

diagnosis; sensitivity; specificity; rapid diagnostic test; molecular biology; LAMP; RT-PCR; serology; ELISA; immune trypanolysis; clinical symptom

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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.

  6 months

Study Arms (1)

Clinical suspect

EXPERIMENTAL

Diagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS

Diagnostic Test: Rapid diagnostic test (RDT); Diagnostic Test: Serological and molecular tests on DBS

Interventions

Rapid diagnostic test (RDT) DIAGNOSTIC_TEST

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.

Also known as: 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)

Clinical suspect

Serological and molecular tests on DBS DIAGNOSTIC_TEST

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

Also known as: 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

Clinical suspect

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Ministry of Public Health, Democratic Republic of the Congo: collaborator
• Ministry of Health, Guinea: collaborator
• Institut National de Sante Publique: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• CIRDES: collaborator
• Institute of Tropical Medicine, Belgium: collaborator
• University of Liverpool: collaborator

Study Sites (3)

Institut Pierre Richet, Institut National de Santé Publique

Bouaké, Côte d’Ivoire

Location

Programme Nationale de Lutte contre la trypanosomiase humaine Africaine

Kinshasa, Democratic Republic of the Congo

Location

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

Conakry, Guinea

Location

Related Publications (15)

• 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.

  PMID: 27058033 BACKGROUND

• 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.

  PMID: 25786994 BACKGROUND

• 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.

  PMID: 25103304 BACKGROUND

• 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.

  PMID: 24750463 BACKGROUND

• 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.

  PMID: 20682885 BACKGROUND

• 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.

  PMID: 21200417 BACKGROUND

• 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.

  PMID: 25642701 BACKGROUND

• 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.

  PMID: 25329353 BACKGROUND

• 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.

  PMID: 24147176 BACKGROUND

• 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.

  PMID: 21829736 BACKGROUND

• 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.

  PMID: 22745836 BACKGROUND

• 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.

  PMID: 8907397 BACKGROUND

• 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.

  PMID: 41021650 DERIVED

• 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.

  PMID: 36941656 DERIVED

• 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.

  PMID: 34460829 DERIVED

MeSH Terms

Conditions

Trypanosomiasis, African; Trypanosomiasis; Infections; Disease; Hypersensitivity

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System 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

• Veerle Lejon, PhD

  Institut de Recherche pour le Developpement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The reference laboratory, generating the results for 4 index tests, is masked for index test and reference test results obtained at the clinical trial site
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Sequential assignement

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 29, 2017
• Study Start: August 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (1); DE (1); GU (1)