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Sleeping Sickness clinical trials

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NCT ID: NCT05645822 Withdrawn - Clinical trials for Trypanosomiasis, African

Screen and Treat Implementation for HAT Control

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO. The development of fexinidazole as treatment is a huge step towards this achievement; however, the diagnostic algorithm remains complex due to limited sensitivity and specificity of the available tests. A combination of serological screening and confirmation of infection through parasite visualization remains the preferred strategy, although it can be difficult to ensure its full performance in areas that are hard to reach or have limited access to electricity and other means. The present study would like to test an approach of ensuring treatment with fexinidazole of sero-suspects without confirmation of disease, among patients that consult fixed health infrastructures in the provinces of Maniema, Lomami and Tanganyika. This should enable access to gHAT treatment for patients living in hard to reach areas, actively seeking health care.

NCT ID: NCT05466630 Recruiting - Sleeping Sickness Clinical Trials

Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis

SpeSerTryp
Start date: June 20, 2022
Phase: N/A
Study type: Interventional

This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense.

NCT ID: NCT05433350 Recruiting - Clinical trials for Trypanosomiasis, African

Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients

OXA005
Start date: July 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Acoziborole has been studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in the DRC and Guinea. As the numbers of reported cases diminish, resources for surveillance and specialised screening will also taper. This decrease, coupled with the loss of diagnostic skills and disease management expertise, will lead to a weak and less specialised HAT technical environment. The history of g-HAT has shown that outbreaks or re-emergence of the disease have already happened under different circumstances when surveillance was relaxed or simply because the populations at risk live in areas of political instability, limiting access to specialised care. Even with a steady decrease of reported incidence, no model can currently predict that HAT could not re-emerge. Although g-HAT is predominantly a disease of adults, children are also affected at diverse rates depending on the geographical and behavioural characteristics in the different areas of disease transmission. Hence efforts are needed to develop a paediatric formulation from a new generation of oral HAT treatments.

NCT ID: NCT05256017 Completed - Clinical trials for Trypanosomiasis, African

Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects

OXA004
Start date: December 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Acoziborole as an oral, single-dose treatment was studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in DRC and Guinea. The safety and efficacy results on g-HAT confirmed cases (all disease stages) from the pivotal study provided data, that allows to envision the treatment of confirmed g-HAT cases but there is still a gap in the management of g-HAT seropositive non-parasitologically confirmed individuals. Indeed, the standard g-HAT case definition implies the demonstration of the parasite in any body fluid via microscopy. However, there are factors such as low parasitaemia and the complexity and low sensitivity of parasitological methods that make such demonstration difficult. It has been demonstrated that a variable proportion (mainly depending on the prevalence) of such g-HAT "sero-suspects" are confirmed cases and, therefore, remaining as potential reservoirs of the parasite and a source of new infections hindering the efforts to eliminate the disease. The present clinical trial intends to expand the safety data of acoziborole and complement the safety profile obtained from the pivotal trial by assessing the safety and tolerability of a single dose of acoziborole compared with placebo in seropositive individuals who are not confirmed parasitologically. In addition to this study, an exploratory sub-study named 'TrypSkin' is planned to assess the presence of extravascular dermal T.b. gambiense in the population enrolled.

NCT ID: NCT04099628 Completed - Sleeping Sickness Clinical Trials

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring

DiTECT-HAT-WP3
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This 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.

NCT ID: NCT03087955 Completed - Clinical trials for Trypanosomiasis, African

Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense

OXA002
Start date: October 11, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to assess efficacy and safety of Acoziborole (SCYX-7158) given as a single dose oral treatment for adult patients (above or equal 15) in the fasting state with T.b. Gambiense HAT

NCT ID: NCT03025789 Completed - Clinical trials for Trypanosomiasis, African

Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

Start date: November 10, 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status. Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 18 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms. Participants receiving treatment at home will also complete questionnaires to check that instructions for fexinidazole administration are clear enough and followed correctly.

NCT ID: NCT01685827 Completed - Sleeping Sickness Clinical Trials

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

Start date: October 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not inferior to NECT treatment.