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Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection (DiTECT-WP2)

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ClinicalTrials.gov Identifier: NCT03356665
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
Ministry of Public Health, Democratic Republic of the Congo
Ministry of Health, Guinea
Institut National de Sante Publique
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
CIRDES
Institute of Tropical Medicine, Belgium
University of Liverpool
Information provided by (Responsible Party):
Institut de Recherche pour le Developpement

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

Condition or disease Intervention/treatment Phase
African Trypanosomiases West African; Trypanosomiasis Sleeping Sickness; West African Trypanosoma Brucei Gambiense; Infection Diagnostic Test: Rapid diagnostic test (RDT) Diagnostic Test: Serological and molecular tests on DBS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Sequential assignement
Masking: None (Open Label)
Masking Description: 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
Primary Purpose: Diagnostic
Official Title: Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clinical suspect
Diagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS
Diagnostic Test: Rapid diagnostic test (RDT)
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.
Other Names:
  • 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)

Diagnostic Test: Serological and molecular tests on DBS
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
Other Names:
  • 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




Primary Outcome Measures :
  1. 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 ]

    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


  2. Specificity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on HAT clinical suspects [ Time Frame: 6 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356665


Locations
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Congo, The Democratic Republic of the
Programme Nationale de Lutte contre la trypanosomiase humaine Africaine
Kinshasa, Congo, The Democratic Republic of the
Côte D'Ivoire
Institut Pierre Richet, Institut National de Santé Publique
Bouaké, Côte D'Ivoire
Guinea
Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie
Conakry, Guinea
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Ministry of Public Health, Democratic Republic of the Congo
Ministry of Health, Guinea
Institut National de Sante Publique
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
CIRDES
Institute of Tropical Medicine, Belgium
University of Liverpool
Investigators
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Principal Investigator: Veerle Lejon, PhD Institut de Recherche pour le Developpement
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT03356665    
Other Study ID Numbers: DiTECT-HAT-WP2
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherche pour le Developpement:
diagnosis
sensitivity
specificity
rapid diagnostic test
molecular biology
LAMP
RT-PCR
serology
ELISA
immune trypanolysis
clinical symptom
Additional relevant MeSH terms:
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Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases