A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo

Human African trypanosomiasis (HAT), also known as sleeping sickness, is an infectious disease caused by the parasite Trypanosoma brucei (T b) gambiense or T b rhodesiense which usually has a fatal outcome after two to three years if left untreated (Buscher et al., 2017; Sudarshi et al., 2014). The parasite is transmitted by tsetse flies that are only present in a number of Sub-Saharan African countries. The West African variant caused by T b gambiense (g-HAT) is the most common form of the disease, accounting for over 95% of worldwide cases, and 90% of those are diagnosed in the Democratic Republic of the Congo (DRC) (Buscher et al., 2017; Lumbala et al., 2015). HAT evolves through two stages, the haemo-lymphatic stage, and the meningo-encephalitic stage. During the first stage, symptoms are not very specific and include fever, itching and joint pains. Later, in the second stage, more specific symptoms develop such as behavioural changes, sensory and motor disturbances, and alteration in the sleeping-waking cycle that is so typical for this disorder. Intramuscular pentamidine injections are the standard treatment for first-stage g-HAT; second-stage is typically treated with nifurtimox-eflornithine combination therapy (NECT), which requires one week of intravenous infusions of eflornithine and ten days of nifurtimox per os. Given the significant logistical and financial challenges related to NECT therapy and the fact that 14% of treated patients EBioMedicine 27 (2018) 11–17 ⁎ Corresponding author at: Unit of Epidemiology and Control of Tropical Diseases, Department of Public Health, Institute of Tropical Medicine, Antwerp B-2000, Belgium. E-mail addresses: (M. Boelaert), (D. Mukendi), (E. Bottieau), (J.R. Kalo Lilo), (K. Verdonck), (L. Minikulu), (B. Barbé), (P. Gillet), (C.P. Yansouni), (F. Chappuis), (P. Lutumba). 1 Contributed equally