Clinical trials: Trypanosomiasis, African
Human African Trypanosomiasis
Assessment of Recombinant HAT-RDT Specificity
Human African trypanosomiasis HAT, or sleeping sickness, is a tropical disease caused mainly by the parasite Trypanosoma brucei gambiense (gHAT).
- Trial name
- NCT05637632
- Where
- Democratic Republic of the Congo
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
The ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of Human African trypanosomiasis due to Trypanosoma brucei rhodesiense (r-HAT): melarsoprol in patients with stage 2…
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection
- Trial name
- NCT03974178
- Testing
- Fexinidazole
- Where
- 2 sites in Malawi, Uganda
- Volunteers
- 45 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
The purpose of this study is to compare the therapeutic combination of I.V. eflornithine + oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety, in patients suffering from…
- Trial name
- NCT00146627
- Testing
- Eflornithine, Nifurtimox
- Where
- 4 sites in Democratic Republic of the Congo, Republic of the Congo
- Volunteers
- 280 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to…
- Trial name
- NCT00330148
- Testing
- melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d, melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d, nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d
- Where
- Uganda
- Volunteers
- 435 people
- Sponsor
- Epicentre
African Trypanosomiasis, African; Trypanosomiasis, West
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure
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…
- Conditions
- African Trypanosomiasis, African; Trypanosomiasis, West, Sleeping Sickness; West African, Trypanosoma Brucei Gambiense; Infection
- Trial name
- DiTECT-WP4 (NCT03112655)
- Testing
- RNA and neopterin detection
- Where
- Democratic Republic of the Congo
- Volunteers
- 88 people
- Sponsor
- Institut de Recherche pour le Developpement
Visceral Leishmaniasis, Human African Trypanosomiasis
Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
Tropical 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.
- Conditions
- Visceral Leishmaniasis, Human African Trypanosomiasis, Enteric Fever, Melioidosis
- Trial name
- NCT01766830
- Testing
- rk28 ICT, IT LEISH (rK39), Immunochromatographic HAT test
- Where
- 7 sites in Cambodia, Democratic Republic of the Congo and 2 more
- Volunteers
- 1,927 people
- Sponsor
- University Hospital, Geneva
Human African Trypanosomiasis (HAT), Sleeping Sickness
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
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.
- Trial name
- NCT01685827
- Testing
- Fexinidazole, Nifurtimox, Eflornithine
- Where
- 10 sites in Central African Republic, Democratic Republic of the Congo and 1 more
- Volunteers
- 394 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
Human African trypanosomiasis (HAT) or sleeping sickness is a tropical disease which is endemic in sub-Saharan Africa. Most cases of HAT are due to the parasite Trypanosoma brucei gambiense (T.b.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA004 (NCT05256017)
- Testing
- Acoziborole
- Where
- 7 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 1,208 people
- Sponsor
- Drugs for Neglected Diseases
Human African Trypanosomiasis, Sleeping Sickness
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
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…
- Conditions
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection, West African Sleeping Sickness
- Trial name
- DiTECT-HAT-WP3 (NCT04099628)
- Testing
- Rapid diagnostic test (RDT); Serological and molecular tests on DBS
- Where
- 3 sites in Burkina Faso, Côte d’Ivoire and 1 more
- Volunteers
- 13,747 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense
Stop Transmission of Gambiense Human African Trypanosomiasis
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested…
- Trial name
- STROgHAT (NCT07789743)
- Testing
- Acoziborole
- Where
- Democratic Republic of the Congo
- Volunteers
- 2,500 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Human African Trypanosomiasis
Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the…
- Trial name
- NECT-FIELD (NCT00906880)
- Testing
- Nifurtimox-Eflronithine Combination Treatment (NECT)
- Where
- 6 sites in Republic of the Congo
- Volunteers
- 630 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety.
- Trial name
- NECS (NCT00489658)
- Testing
- Eflornithine plus Nifurtimox combination therapy
- Where
- Uganda
- Volunteers
- 31 people
- Sponsor
- Epicentre
Human African Trypanosomiasis
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria
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.
- Trial name
- NCT03394976
- Testing
- No intervention
- Volunteers
- healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
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.
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosomiasis; Gambian
- Trial name
- NCT03025789
- Testing
- Fexinidazole
- Where
- 8 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 174 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
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.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA005 (NCT05433350)
- Testing
- Acoziborole
- Where
- 6 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 35 people
- Sponsor
- Drugs for Neglected Diseases
Human African Trypanosomiasis, Sleeping Sickness
Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis
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.
- Conditions
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection, West African Sleeping Sickness
- Trial name
- SpeSerTryp (NCT05466630)
- Testing
- Serological field test for HAT, malaria rapid test, Immunologic laboratory tests
- Where
- 2 sites in Côte d’Ivoire, Guinea
- Volunteers
- 1,095 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
Human African Trypanosomiasis
Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested…
- Trial name
- STROgHAT (NCT06356974)
- Testing
- Treatment of seropositive individuals (positive serology test, but parasitology not confirmed)
- Volunteers
- 2,500 people
- Sponsor
- Drugs for Neglected Diseases
African Trypanosomiasis
Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers.
- Trial name
- NCT00803933
- Testing
- DB289, Pentamidine
- Where
- 2 sites in Republic of the Congo
- Volunteers
- 111 people
- Sponsor
- Immtech Pharmaceuticals, Inc
African Trypanosomiases, West African; Trypanosomiasis
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
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…
- Conditions
- African Trypanosomiases, West African; Trypanosomiasis, Sleeping Sickness; West African, Trypanosoma Brucei Gambiense; Infection
- Trial name
- DiTECT-WP2 (NCT03356665)
- Testing
- Rapid diagnostic test (RDT), Serological and molecular tests on DBS
- Where
- 3 sites in Côte d’Ivoire, Democratic Republic of the Congo and 1 more
- Volunteers
- 10,700 people
- Sponsor
- Institut de Recherche pour le Developpement
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
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.
- Trial name
- NCT02169557
- Testing
- Fexinidazole
- Where
- Democratic Republic of the Congo
- Volunteers
- 230 people
- Sponsor
- Drugs for Neglected Diseases