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The risk of recurrent Plasmodium vivax malaria and haematological effect of treatment with or without primaquine: a systematic review and individual patient data meta-analysis
Proposal
5769
Title of Proposed Research
The risk of recurrent Plasmodium vivax malaria and haematological effect of treatment with or without primaquine: a systematic review and individual patient data meta-analysis
Lead Researcher
Rob Commons
Affiliation
Menzies School of Health Research, Darwin, Australia WorldWide Antimalarial Resistance Network (WWARN), University of Oxford, UK
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
2 Sep 2019
Lay Summary
Plasmodium vivax, one of five human malaria species, remains widespread, and outside of Africa, it is becoming the dominant cause of malaria. There is increasing recognition that recurrent vivax malaria is associated with recurrent symptomatic illness and anaemia with attributable morbidity and mortality. Recent pooled analyses through the WorldWide Antimalarial Resistance Network (WWARN) have identified the risk factors associated with early recurrence prior to day 42. In addition the analyses have identified the haematological profiles over this period, including the impact of primaquine, an antimalarial which can cause red cell destruction in some people with G6PD deficiency, a genetic condition where the individuals has decreased activity of the G6PD enzymes which are required for some biochemical reactions in the body. However, the risk factors associated with risk of recurrence over a longer duration, including the dose of primaquine and the impact of CYP2D6, a liver enzyme that reacts with drugs, have not been comprehensively evaluated. In addition, the haematological response over a longer duration and its association with multiple recurrences need further exploration, including the impact of G6PD deficiency. If the longer term risks and benefits of radical cure are to be quantified, there is a need to further understand the factors that impact on multiple recurrences.
Study Data Provided
[{ "PostingID": 4589, "Title": "GSK-TAF112582", "Description": "A multi-centre, double-blind, randomised, parallel-group, active controlled study to evaluate the efficacy, safety and tolerability of tafenoquine (SB-252263, WR238605) in subjects with Plasmodium vivax malaria." },{ "PostingID": 19835, "Title": "GSK-TAF116564", "Description": "A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) versus Primaquine in the Treatment of Subjects with Plasmodium vivax Malaria" }]
Statistical Analysis Plan
Publication Citation
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