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

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

Conditions

• African Trypanosomiases
• West African; Trypanosomiasis
• Sleeping Sickness; West African
• Trypanosoma 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

Sponsors & Collaborators

• Ministry of Public Health, Democratic Republic of the Congo

  collaborator OTHER_GOV

• Ministry of Health, Guinea

  collaborator OTHER_GOV

• Institut National de Sante Publique

  collaborator OTHER

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

  collaborator OTHER

• CIRDES

  collaborator UNKNOWN

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Institut de Recherche pour le Developpement

  lead OTHER_GOV

Principal Investigators

• Veerle Lejon, PhD · Institut de Recherche pour le Developpement

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2021-01-31

Completion

2021-01-31

Countries

• Côte d’Ivoire
• Democratic Republic of the Congo
• Guinea

Study Locations