This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam. Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other. Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment. The results of the study will be used to inform malaria treatment guidelines in Viet Nam.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
330
Bu Gia Map Health Station
Phước Hòa, Binh Phuoc, Vietnam
Proportion of patients with adequate response to treatment
Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
Time frame: Day 63
Proportion of patients classified as Early Treatment Failures
One or more of the following: * danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia; * parasitaemia on day 2 higher than on day 0, irrespective of temperature; * parasitaemia on day 3 with temperature ≥ 37.5 ºC; * parasitaemia on day 3 ≥ 25% of count on day 0.
Time frame: Day 63
The parasite clearance time
Defined as the time in hours from the first treatment dose to the first of two consecutive parasitemia counts of zero.
Time frame: Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.
Fever clearance time
Defined as the time in hours from the first treatment dose to the start of the first sustained period of 24 hours without fever
Time frame: Assessed every 6 hours until Day 3, or 24 hours without fever
Frequency of adverse and serious adverse events
Time frame: Day 63
Proportion of patients classified as Late Clinical Failures
One or more of the following: * danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 63 in patients who did not previously meet any of the criteria of early treatment failure; * presence of parasitaemia on any day between day 4 and day 63 with temperature ≥ 37.5 ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure
Time frame: Day 63
Proportion of patients classified as Late Parasitological Failures
Presence of parasitaemia on any day between day 7 and day 63 with temperature \< 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure
Time frame: Day 63
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