Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
This is an open label two-arm randomized prospective study of two treatments for P. vivax
malaria. Patients meeting study inclusion criteria will be enrolled and allocated either
chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will
be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients
with recurrent P. vivax infection will be treated with the same medication as initially
randomized unless contraindicated. Recurrences in the two arms will be compared to estimate
the risk of and mean duration to relapse, classify the relapse pattern as early or late
relapse and to estimate the efficacy and safety of the study drugs.
Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish
between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be
collected on day 7 from each study subject as well as on the day of recurrence if within 8
weeks of chloroquine
Phase:
Phase 4
Details
Lead Sponsor:
University of Oxford
Collaborators:
Mahidol University National Malaria and Leishmaniasis Control Program, Afghanistan