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

NACompletedINTERVENTIONAL
Enrollment

10,700

Participants

Timeline

Start Date

August 1, 2017

Primary Completion Date

January 31, 2021

Study Completion Date

January 31, 2021

Conditions
African TrypanosomiasesWest African; TrypanosomiasisSleeping Sickness; West AfricanTrypanosoma Brucei Gambiense; Infection
Interventions
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.

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

Trial Locations (3)

Unknown

Institut Pierre Richet, Institut National de Santé Publique, Bouaké

Programme Nationale de Lutte contre la trypanosomiase humaine Africaine, Kinshasa

Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie, Conakry

All Listed Sponsors
collaborator

Ministry of Public Health, Democratic Republic of the Congo

OTHER_GOV

collaborator

Ministry of Health, Guinea

OTHER_GOV

collaborator

Institut National de Sante Publique

OTHER

collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

collaborator

CIRDES

UNKNOWN

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

University of Liverpool

OTHER

lead

Institut de Recherche pour le Developpement

OTHER_GOV

NCT03356665 - Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection | Biotech Hunter | Biotech Hunter