Clinical trial NCT03394976: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Human African Trypanosomiasis
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Ministry of Public Health, Democratic Republic of the Congo
First posted: 2018-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: specificity of the HAT/malaria combo test for gambiense HAT in passive screening
timeFrame: Enrolment
measure: specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening
timeFrame: Enrolment
measure: sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening
timeFrame: Enrolment
measure: sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening
timeFrame: Enrolment
measure: specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening
timeFrame: Enrolment
measure: specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening
timeFrame: Enrolment
Secondary outcomes:
measure: specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic
timeFrame: Enrolment
measure: 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
timeFrame: Enrolment
measure: 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
timeFrame: Enrolment
measure: 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
timeFrame: Enrolment
Other outcomes:
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