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

Brief Title

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

Official Title

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

Interventional


Primary Outcome

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


Condition

African Trypanosomiases

Intervention

Rapid diagnostic test (RDT)

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

10700

Start Date

August 1, 2017

Completion Date

January 31, 2021

Primary Completion Date

January 31, 2021

Eligibility 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
      

Gender

All

Ages

4 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Veerle Lejon, PhD, , 

Location Countries

Congo, The Democratic Republic of the

Location Countries

Congo, The Democratic Republic of the

Administrative Informations


NCT ID

NCT03356665

Organization ID

DiTECT-HAT-WP2


Responsible Party

Sponsor

Study Sponsor

Institut de Recherche pour le Developpement

Collaborators

 Ministry of Public Health, Democratic Republic of the Congo

Study Sponsor

Veerle Lejon, PhD, Principal Investigator, Institut de Recherche pour le Developpement


Verification Date

February 2021