WP4: Early test of cure

Work Package 4 Overview

Goal:

To determine the accuracy of SL-RNA detection in blood and cerebrospinal fluid and of neopterin quantification in cerebrospinal fluid, for assessing treatment outcome.

Work package 4 (WP4) aims at identifying an early test-of-cure and deals with pre- and post-treatment collection of specimens in ongoing therapeutic trials. Today, therapeutic trials provide the only working environment enabling the evaluation of new candidate tests-of-cure. The only organisation conducting therapeutic trials on HAT is DNDi. DiTECT-HAT therefore works in close collaboration with DNDi for this work package.  Combination of WP4 with the clinical trial on SCYX-7158 allows evaluation of new treatment outcome assessment markers during follow-up without the need for additional lumbar or venipunctures.  DNDi will provide biological specimens taken during and after a therapeutic trial to DiTECT-HAT. Reverse transcriptase real time PCR for spliced leader RNA detection in blood and cerebrospinal fluid and neopterin detection will be carried out in the reference laboratory in Kinshasa.  For data analysis, Classification of patients as treatment failure or treatment success after 18 months, according to the clinical trial criteria will be used as reference standard to compare our index tests. WP4 will be carried in DR Congo with PNLTHA and INRB as main participants.