Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Brief Title

Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Official Title

Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria

Brief Summary

      A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African
      trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has
      recently been developed. The performance of this prototype has been evaluated in a
      retrospective study that showed that its diagnostic performance for HAT and malaria was
      equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f
      tests, respectively.

      The purpose of this study is to prospectively evaluate the performance of the test in
      settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic
      for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a
      diagnostic test for malaria, and a screening test for HAT in pre-elimination and
      post-elimination contexts, respectively.
    



Study Type

Observational


Primary Outcome

specificity of the HAT/malaria combo test for gambiense HAT in passive screening

Secondary Outcome

 specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic

Condition

Human African Trypanosomiasis

Intervention

No intervention

Study Arms / Comparison Groups

 Study population
Description:  Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.

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

2500

Start Date

January 2020

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Age greater than or equal to 6 years

          -  Provision of signed informed consent. For children (under the age of 18) provision of
             signed informed consent by a parent or legal guardian and an age appropriate assent.

        Exclusion Criteria:

          -  Severe anaemia preventing collection of a sample of venous blood

          -  Severe medical condition preventing informed consent and trial participation (e.g.
             coma, cognitive impairment, etc.)

          -  For HAT true negatives only: history of previous HAT infection
      

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, +41227100590, [email protected]



Administrative Informations


NCT ID

NCT03394976

Organization ID

HAT-malaria RDT evaluation


Responsible Party

Sponsor

Study Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Collaborators

 Makerere University

Study Sponsor

, , 


Verification Date

February 2019