Clinical trials: Radical Cure
Malaria, Vivax, Relapse
Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia
Primaquine (PQ) is the only widely available treatment to prevent P. vivax relapses. World Health Organization recommends increased PQ doses in East Asia and Oceania, frequently relapsing strains.
- Trial name
- NCT05232227
- Testing
- Primaquine double dose over 14 days, Primaquine single dose over 14 days
- Sponsor
- University of California, San Francisco
Malaria
An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria
Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects.
- Trial name
- PRIMUS (NCT07468526)
- Testing
- High dose ultra short Primaquine
- Where
- 5 sites in Ethiopia, Indonesia and 2 more
- Volunteers
- 1,019 people
- Sponsor
- Menzies School of Health Research
Malaria, Vivax, Therapeutics
DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil
Plasmodium vivax can be cause of severe malaria and mortality. There are serious public health implications associated with cases of P.
- Trial name
- CuraVivax (NCT03208907)
- Testing
- CQ coadministered with PQ, DHA-PQP coadministered with PQ, CQ and PQ starting on Day 42
- Where
- Brazil
- Volunteers
- 419 people
- Sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Uncomplicated Vivax Malaria
IMPROV (Improving the Radical Cure of Vivax Malaria)
The main determinant of primaquine efficacy is the total dose of primaquine administered, rather than the dosing schedule. Previous trials have demonstrated that the standard low dose regimen of primaquine (3.5 mg/kg total) fails…
- Trial name
- NCT01814683
- Testing
- Primaquine
- Where
- 8 sites in Afghanistan, Ethiopia and 2 more
- Volunteers
- 2,388 people
- Sponsor
- University of Oxford
Uncomplicated Malaria
Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria
Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide.
- Trial name
- NCT07403643
- Testing
- Single dose tafenoquine (10 mg/kg), Dihydroartemisinin-piperaquine (DHA-PPQ), Artemether + Lumefantrine
- Where
- Papua New Guinea
- Volunteers
- 60 people
- Sponsor
- Curtin University
Malaria, Malaria, Vivax
Short Course Radical Cure of P. Vivax Malaria in Nepal
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD)…
- Conditions
- Malaria, Malaria, Vivax, Malaria,Falciparum
- Trial name
- NCT04079621
- Testing
- primaquine
- Where
- 2 sites in Nepal
- Volunteers
- 27 people
- Sponsor
- Menzies School of Health Research
Malaria, Vivax
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
- Trial name
- NCT06666491
- Testing
- Tafenoquine, Primaquine, Chloroquine
- Where
- 5 sites in India
- Volunteers
- 324 people
- Sponsor
- GlaxoSmithKline
Vivax Malaria, G6PD Deficiency
Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia
The proportion of malaria that is the Plasmodium vivax species is increasing in Indonesia. Reducing vivax malaria will require innovative solutions to cure both the blood and liver stages of the disease.
- Trial name
- SCOPE (NCT05879224)
- Testing
- Revised case management package
- Where
- 6 sites in Indonesia
- Volunteers
- 2,999 people
- Sponsor
- Menzies School of Health Research
Malaria, Malaria, Vivax
Vivax Elimination With Tafenoquine (VET) Study
Theoretically, so long as there is a sink-source for malaria, transmission could be sustained at very low level (even at sub-microscopic oscillation) and reintroduce malaria either as sporadic cases or as resurgent outbreak.
- Conditions
- Malaria, Malaria, Vivax, Plasmodium Vivax, Plasmodium Vivax Malaria
- Trial name
- VET (NCT06575647)
- Testing
- Tafenoquine
- Where
- Thailand
- Volunteers
- 1,242 people
- Sponsor
- Shoklo Malaria Research Unit
Malaria, Vivax, G6PD Deficiency
Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
This is an observational study carried out in Brazil in patients with P. vivax malaria. The study will be carried out in the municipalities of Manaus (state of Amazonas) and Porto Velho (state of Rondônia).
- Trial name
- Trust (NCT05096702)
- Testing
- Tafenoquine, Primaquine
- Where
- 41 sites in Brazil
- Volunteers
- 16,000 people
- Sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Malaria, Vivax
Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
The goal of this study is to evaluate the operational feasibility of using a new treatment algorithm for Malaria Vivax in Peru. The implementation package includes the following interventions: A revised vivax treatment algorithm…
- Trial name
- NCT05361486
- Testing
- Tafenoquine (TQ)
- Where
- Peru
- Volunteers
- 187 people
- Sponsor
- Medicines for Malaria Venture
Vivax Malaria
Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD)
In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden of disease than Plasmodium falciparum (Pf).
- Trial name
- NCT01640574
- Testing
- Dihydroartemisinin-Piperaquine, Chloroquine
- Where
- Thailand
- Volunteers
- 680 people
- Sponsor
- University of Oxford
Malaria, Vivax, G6PD Deficiency
Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand
The purpose of this prospective, observational study is to assess the operational feasibility of appropriate radical cure treatment for P.
- Trial name
- ARCTIC (NCT05753150)
- Testing
- Tafenoquine, Primaquine
- Where
- 9 sites in Thailand
- Volunteers
- 187 people
- Sponsor
- Dr. Prayuth Sudathip
Plasmodium Vivax Malaria, Vivax Malaria
Tafenoquine Drug Levels in Small Children
This study is an open label, single arm, pharmacokinetic trial. A total of 20 participants (children ≤12kg and >28 days old) will be enrolled.
- Trial name
- TQP (NCT07835321)
- Testing
- Chloroquine, Tafenoquine
- Where
- 2 sites in Thailand, Vietnam
- Volunteers
- 20 people
- Sponsor
- University of Oxford
Malaria, Vivax
Study to Evaluate Primaquine for Radical Cure of Uncomplicated Plasmodium Vivax Malaria in Children
The main determinant of primaquine efficacy is the total dose of primaquine administered, rather than the dosing schedule. Infants and children younger than 4 years of age are at a higher risk of frequent relapses than older age…
- Trial name
- CHILDPRIM (NCT05044637)
- Testing
- Primaquine
- Where
- 2 sites in Brazil
- Volunteers
- 100 people
- Sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Plasmodium Vivax Malaria
Southeast Asia Dose Optimization of Tafenoquine
Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the…
- Trial name
- SEADOT (NCT04704999)
- Testing
- Tafenoquine, Chloroquine, Artemether 20 mg-Lumefantrine 120 mg
- Where
- 6 sites in Cambodia, Indonesia and 3 more
- Volunteers
- 820 people
- Sponsor
- University of Oxford
Vivax Malaria
Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be…
- Trial name
- NCT04706130
- Testing
- Primaquine, Artesunate
- Where
- Cambodia
- Volunteers
- 160 people
- Sponsor
- University of Maryland, Baltimore
Vivax Malaria, G6PD Deficiency
Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax. P.
- Trial name
- SCOPE (NCT05874271)
- Testing
- Revised case management package
- Where
- 4 sites in Papua New Guinea
- Volunteers
- 794 people
- Sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd