Eight Week Primaquine Regimen for the Treatment of Vivax Malaria
Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school.
Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Placebo Controlled, Randomised Evaluation of an Eight Week Primaquine Regimen for the Treatment of Vivax Malaria.|
- Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. [ Time Frame: 2004-March 2007 ]
- Secondary Efficacy Variables: Time to subsequent relapse episode [ Time Frame: 2004-March 2007 ]
- Number of relapse episodes in 12 months [ Time Frame: 2004-March 2007 ]
- Side effects / adverse events [ Time Frame: 2004-March 2007 ]
|Study Start Date:||April 2004|
|Study Completion Date:||March 2007|