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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394976
Recruitment Status : Not yet recruiting
First Posted : January 9, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Makerere University
Ministry of Public Health, Democratic Republic of the Congo
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

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.


Condition or disease Intervention/treatment
Human African Trypanosomiasis Diagnostic Test: No intervention

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
Study population
Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. specificity of the HAT/malaria combo test for gambiense HAT in passive screening [ Time Frame: Enrolment ]
  2. specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening [ Time Frame: Enrolment ]
  3. sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening [ Time Frame: Enrolment ]
  4. sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening [ Time Frame: Enrolment ]
  5. specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening [ Time Frame: Enrolment ]
  6. specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening [ Time Frame: Enrolment ]

Secondary Outcome Measures :
  1. specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic [ Time Frame: Enrolment ]
  2. specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic [ Time Frame: Enrolment ]
  3. specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic [ Time Frame: Enrolment ]
  4. specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic [ Time Frame: Enrolment ]


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

The study will focus on passive screening, which is the intended use of the test.

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

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): NCT03394976


Contacts
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Contact: Sylvain Biéler, PhD +41227100590 sylvain.bieler@finddx.org

Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
Makerere University
Ministry of Public Health, Democratic Republic of the Congo
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03394976    
Other Study ID Numbers: HAT-malaria RDT evaluation
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Trypanosomiasis
Trypanosomiasis, African
Protozoan Infections
Parasitic Diseases
Euglenozoa Infections