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Trypanosomiasis clinical trials

View clinical trials related to Trypanosomiasis.

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NCT ID: NCT03394976 Withdrawn - Clinical trials for Human African Trypanosomiasis

Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Start date: January 31, 2022
Phase:
Study type: Observational

A 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.

NCT ID: NCT03356665 Completed - Clinical trials for Trypanosoma Brucei Gambiense; Infection

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection

DiTECT-WP2
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The 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

NCT ID: NCT03112655 Completed - Clinical trials for Trypanosoma Brucei Gambiense; Infection

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure

DiTECT-WP4
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

The 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.

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 human African trypanosomiasis due to T. b. gambiense (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. Treatment compliance, feasibility, and packaging acceptability will be thoroughly assessed in the participants receiving treatment at home. Those participants will complete questionnaires to check that instructions for fexinidazole administration are clear enough and followed correctly.

NCT ID: NCT02571062 Completed - Clinical trials for Trypanosomiasis, African

Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation

Start date: March 2015
Phase: Phase 1
Study type: Interventional

Phase 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.

NCT ID: NCT02498782 Recruiting - Chagas Disease Clinical Trials

Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The hypothesis is to evaluate if the treatment with Fexinidazole will lead to a better sustained clearance of the parasites at 6 months of follow-up when in comparison to placebo in patients with chronic indeterminate CD.

NCT ID: NCT02369978 Recruiting - Chagas Disease Clinical Trials

CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)

CHICAMOCHA-3
Start date: August 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This randomized, blind, parallel-group trial will evaluate the efficacy and safety of Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite Trypanosoma cruzi. The investigators will test whether NFX is an effective trypanocidal agent (by comparison with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related and safety outcomes. Individuals found seropositive and without clinical signs of dilated cardiomyopathy will receive either of the active treatments or matching placebo. Participants allocated to NFX or BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment, whereas the control group will receive placebo for 120 days. There will be thus four arms of active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving placebo (1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days of study drug (the groups receiving full-dose will complete a 120-day masked treatment with placebo). The study plans to enroll 500 participants from Colombia (in two different geographical areas) and Argentina, in order to explore regional differences in the treatment effects.

NCT ID: NCT02184689 Completed - Clinical trials for Human African Trypanosomiasis (HAT)

Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

Start date: May 3, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping sickness in children at least 6 years old and over 20 kg bodyweight.

NCT ID: NCT02169557 Completed - Clinical trials for Human African Trypanosomiasis (HAT)

Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study

Start date: April 30, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the treatment success of fexinidazole, at one year follow-up visit, in HAT stage 1 and early stage 2 patients.