DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection (ACTQ)
Malaria, Malaria, Vivax, Plasmodium Vivax Malaria
About this trial
This is an interventional treatment trial for Malaria focused on measuring artemisinin combination treatment, tafenoquine, Plasmodium vivax malaria, Malaria
Eligibility 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
Sites / Locations
- Shoklo Malaria Research Unit (SMRU)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dihydroartemisinin-piperaquine plus tafenoquine (450 mg adult dose)
Chloroquine plus Tafenoquine (450 mg adult dose)
Dihydroartemisinin-Piperaquine will be purchased as Duo-Cotecxin® Beijing Holley-Cotec Pharmaceuticals Co., Ltd, China). One tablet contains 40 mg of dihydroartemisinin and 320 mg piperaquine (i.e. a 1:8 ratio). A weight-based regimen containing a total dose of approximately 7 mg/kg DHA and 55 mg/kg piperaquine given in 3 divided doses once daily. Tafenoquine KOZENIS® 150 mg film-coated tablets will be purchased from GSK (Glaxo Smith Kline Pharmaceutical industry), 450 mg (3 tablets) will be given.
Chloroquine will be dosed as a 25 mg/kg base given in divided doses of 10 mg/kg orally on days 0 and 1, and in 5 mg/kg dose on day 2. Tablets will be obtained from Government Pharmaceutical Organization (GPO) in Bangkok, Thailand and supplied as 250 mg tablets (155.3 mg base). Tafenoquine KOZENIS® 150 mg film-coated tablets will be purchased from GSK (Glaxo Smith Kline Pharmaceutical industry), 450 mg (3 tablets) will be given.