In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug that will make it more difficult for the mosquito to drink up the malaria in people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop in the mosquito so it will not be able to inject malaria back into people when it bites. The drug the investigators will use is called primaquine. Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red cells need enzymes to work properly and weak red cells have low amounts of an enzyme called glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria with primaquine will be safe for the red cells. To do this study, the investigators need to know if a subject has low G6PD or not.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Ratanakiri Provincial Hospital
Ratanakiri, Ratanakiri, Cambodia
Haemoglobin concentration
Compare haemoglobin concentrations in g/dL between the G6PD deficient arm given DHA PP plus primaquine, and the G6PD normal arm receiving the same regimen
Time frame: Day 7
Determine G6PD enzyme activity
Quantitative G6PD testing among all participants using the G6PD enzyme assay from Trinity Biologicals, USA, yielding G6PD enzyme results in U/g Hb.
Time frame: Day 0
Assess usefulness of field adapted WHO haemoglobin colour card vs. Hemocue
Comparison of quantitative (HemoCue, g/dL HB) and qualitative (WHO haemolglobin colour card) estimates of haemoglobin concentration
Time frame: Day 0
Assess usefulness of rapid test for G6PDd in predicting acute intravascular haemolysis
Comparison of rapid G6PD test (AccessBio, USA) qualitative result against quantitative G6PD assay to determine predictive value for clinically significant haemolysis
Time frame: Day 0
Proportion patients with ≥25% change in haemoglobin as a marker of intravascular haemolysis
Comparing across all 4 arms: proportion of all patients with fractional change in haemoglobin ≥25% from day 0 to day 7
Time frame: Change from Day 0 to Day 7
Plasma haemoglobin concentration as a marker of intravascular haemolysis
Comparing across all 4 arms: plasma haemoglobin concentration at day 7
Time frame: Day 7
Urine colour change as a marker of intravascular haemolysis
Change in urine colour grade from day 0 to day 7 (Hillmen, Hall et al. 2004)
Time frame: Change from Day 0 to Day 7
Fractional change in haemoglobin as a marker of intravascular haemolysis
Comparing across all 4 arms: fractional change in haemoglobin on day 7 vs. day 0
Time frame: Change from Day 0 to Day 7
Clearance rate of primaquine
Primaquine elimination clearance rate, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Time frame: Day 0-7
Half life of primaquine
Primaquine terminal elimination half life, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Time frame: Day 0-7
Primaquine volume of distribution
Primaquine apparent volume of distribution (Vd), modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Time frame: Day 0-7
Clearance rate of piperaquine
Piperaquine elimination clearance rate, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Time frame: Day 0-28
Half life of piperaquine
Piperaquine terminal elimination half life, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Time frame: Day 0-28
Piperaquine volume of distribution
Piperaquine apparent volume of distribution (Vd), modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Time frame: Day 0-28
Peak plasma concentration (Cmax) of primaquine
Cmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Time frame: Day 0-7
Peak plasma concentration (Cmax) of piperaquine
Cmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Time frame: Day 0-28
Time to primquine peak plasma concentration (Tmax)
Tmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Time frame: Day 0-7
Time to piperaquine peak plasma concentration (Tmax)
Tmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Time frame: Day 0-28
Area under the plasma concentration versus time curve - primaquine
Modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Time frame: Day 0-7
Area under the plasma concentration versus time curve - piperaquine
Modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Time frame: Day 0-28
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