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Trial record 2 of 3 for:    DiTECT-HAT

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

Tracking Information
First Submitted Date  ICMJE November 24, 2017
First Posted Date  ICMJE November 29, 2017
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
Official Title  ICMJE Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • African Trypanosomiases
  • West African; Trypanosomiasis
  • Sleeping Sickness; West African
  • Trypanosoma Brucei Gambiense; Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Clinical suspect
Diagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS
Interventions:
  • Diagnostic Test: Rapid diagnostic test (RDT)
  • Diagnostic Test: Serological and molecular tests on DBS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2020)
10700
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2017)
20000
Actual Study Completion Date  ICMJE January 31, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Côte D'Ivoire,   Congo, The Democratic Republic of the,   Guinea
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03356665
Other Study ID Numbers  ICMJE DiTECT-HAT-WP2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut de Recherche pour le Developpement
Study Sponsor  ICMJE Institut de Recherche pour le Developpement
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Veerle Lejon, PhD Institut de Recherche pour le Developpement
PRS Account Institut de Recherche pour le Developpement
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP