Vivax Malaria Clinical Trial
Official title:
Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy
This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for
Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients
with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for
28 days so as to study the efficacy of CQ alone.
This study will assess whether CQ is still effective against P.vivax or whether there are
resistant P.vivax strains in Bhutan.
This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until
day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood
stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences
before day 28, will be treated with second line treatment (ACT).
The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent
infection will de determined to assess whether that could be due to resistance, or due to
low level of Chloroquine.
Any relapses occurring after day 28 when not receiving Primaquine, or after completion of
Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat
doses of the initial treatment. The recurrence rates will be recorded so as to develop the
next phase of the study where the two different doses of Primaquine (high dose vs. low dose)
will be compared.
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Observational Model: Cohort, Time Perspective: Prospective
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