Study design and participants
HAT infection
SEVERE MALNUTRITION
This multicentre, prospective, open-label, single-arm, phase 2/3 study recruited patients aged 15 years or older with confirmed gambiense HAT infection from ten hospitals in the Democratic Republic of the Congo and Guinea. Late-stage gambiense HAT diagnosis required presence of trypanosomes in the blood, lymph, or CSF (or a combination of either) and more than 20 cells per μL in CSF. Early-stage and intermediate-stage gambiense HAT required the presence of trypanosomes in the blood or lymph (or both), but absence of trypanosomes in the CSF and a CSF white blood cell (WBC) count of 6–20 cells per μL (intermediate stage) or 5 cells per μL or fewer (early stage). Inclusion criteria included a Karnofsky score greater than 50, ability to swallow tablets, a permanent address or traceability, ability to comply with follow-up visits and study requirements, and agreement to hospital admission during treatment. Exclusion criteria were severe malnutrition (BMI <16 kg/m