This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).
This is a randomized, Single blind trial in G6PD normal participants with subclinical P. vivax infections in Laos. Participants with subclinical P. vivax infections and those meeting the enrolment criteria will be randomly assigned to one of two treatment arms: * Intervention: Dihydroartemisinin-piperaquine (DP) therapy 3 days dosing plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg/day). * Control arm: Dihydroartemisinin-piperaquine (DP) 3 days dosing therapy plus 14 days identical primaquine placebo. Participants found to be G6PD deficient (G6PDd) will be treated with primaquine 0.75mg/kg/week for 8 weeks according to WHO recommendations. Primaquine and placebo will be administered with food (biscuits), which has been shown to reduce gastrointestinal side effects. All doses of study drugs will be supervised. If participants cannot visit the study centre, or fail to attend during the 14 days of supervised therapy, team members will visit them in their homes, schools or work to ensure complete dosing. Findings: The study showed that a 14-day course of primaquine added to mass drug administration with dihydroartemisinin-piperaquine prevented recurrent asymptomatic P. vivax infections (doi: 10.1186/s12936-019-3091-5)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
41
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
Vientiane, Laos
The incidence rate of P. vivax parasitaemia in G6PD-normal participants
the incidence rate will be detected by uPCR
Time frame: over 12 months
Time to P. vivax clearance
Detected by uPCR
Time frame: 12 months
The frequency of recurrent vivax infections (clinical and sub-clinical)
Time frame: 12 months
The follow-up period required to detect a statistically significant difference in the frequency of recurrent subclinical P. vivax infections between treated and untreated participants
measured by uPCR
Time frame: 12 months
Number of participants with treatment related Adverse event.
Time frame: 28 days
Number of participants with treatment related malaria episode
Time frame: 12 months
Number of doses taken per participants
Time frame: 14 days
Compare the percentage decrease in hemoglobin between those who receive primaquine and who those not receive primaquine
Time frame: 12 months
Number of G6PD genotypes in participants with G6PD deficiency
Time frame: 12 months
Number of P450 genotypes in participants with recurrent PV infection.
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Time frame: 12 months