Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive...
African TrypanosomiasesWest African; Trypanosomiasis2 moreThe 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
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination...
Human African TrypanosomiasisSleeping Sickness6 moreThis study determines the feasibility, diagnostic performance and cost for monitoring of eliminated human African trypanosomiasis (HAT) foci using diagnostic algorithms of serological and molecular high throughput tests with and without previous rapid diagnostic test blood screening for early detection of Trypanosoma brucei gambiense HAT re-emergence.
Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With...
Visceral LeishmaniasisHuman African Trypanosomiasis10 moreTropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance. In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.
DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and...
TrypanosomiasisAfricanTo assess Drug drug interactions between Acoziborole and Dextromethorphan and Midazolam in healthy male volunteers.
Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation...
TrypanosomiasisAfricanPhase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition. The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate crossover study under fed condition. The 4-period sequences for the replicate design will be TRTR and RTRT, where R designates the reference formulation and T the test formulation. Subject will be allocated randomly to one of the two sequences of treatments according to the randomization list.
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure...
African TrypanosomiasisAfrican; Trypanosomiasis3 moreThe study validates the diagnostic performance of cerebrospinal fluid neopterin quantification and of blood and cerebrospinal fluid trypanosomal spliced leader RNA detection for assessing outcome after treatment of human African trypanosomiasis.
A Retrospective Analysis of Suramin Treatment for Stage 1 TBR
Trypanosoma Brucei Rhodesiense; InfectionThe study will include TBR HAT patients treated with suramin between 2000 and 2020 at three sites in Uganda and Malawi A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. This study's objectives are to evaluate the efficacy and safety of suramin in the Stage 1 treatment of TBR HAT.
Assessment of Recombinant HAT-RDT Specificity
Human African TrypanosomiasisHuman African trypanosomiasis HAT, or sleeping sickness, is a tropical disease caused mainly by the parasite Trypanosoma brucei gambiense (gHAT). After a severe epidemic in the 1990s, the World Health Organization (WHO) now targets elimination of transmission of gHAT by the year 2030, which heavily relies on its diagnosis and treatment. Traditional screening tests (like CATT or rapid diagnostic tests (RDTs)) are based on the detection of antibodies against the parasite using native antigens, which are costly and dangerous to produce. New serological tests, using recombinant antigens, have been developed, but little is known about their field performance. The primary objective of this study is to assess the specificity of the newly-developed recombinant RDTs, since it will become very relevant as we move forward towards a screen&treat strategy. We will also compare the diagnostic accuracy and overall performance of iELISA and molecular testing.
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria...
Human African TrypanosomiasisA prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively. The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.