DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection

• Status: Not yet recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

Summary

In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shoklo Malaria Research Unit
• Collaborator: Mahidol Oxford Tropical Medicine Research Unit
• Treatments: Artenimol; Chloroquine; Piperaquine; Tafenoquine

Criteria

Inclusion Criteria:

• Patients with P. vivax mono-infection as diagnosed by Rapid Diagnostic Test

• Fever or history of fever in the previous 7 days

• Quantitative G6PD activity ≥70% of the population median i.e., ≥6.1U/gHb

• Age > 18 years, Weight >35 kg

• Ability to understand the study instructions and provide informed consent

• Willing to be followed for 4 months and likely to adhere to the study protocol.

Exclusion Criteria:

• Coincident P. falciparum malaria or other infections

• Pregnancy

• Lactation

• Hb < 8 g/dL

• Quantitative G6PD activity <70% of the population median i.e., <6.1U/gHb

• Severe malaria (as per WHO guideline)

• History of allergic or haemolytic response to any of the study drugs