Ethiopia Antimalarial in Vivo Efficacy Study 2012

• P. vivax treatment failures in the 4 weeks following treatment with AL compared to AL+PQ [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  
• P. vivax treatment failures in the 4 weeks following treatment with CQ compared to CQ+PQ [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  

• Number of episodes of P. vivax parasitemia over one year following initial effective therapy against P. vivax (i.e. parasite clearance) [ Time Frame: 1 year after day 0 of enrollment ] [ Designated as safety issue: No ]
  
• P. vivax treatment failures in the 6 weeks following treatment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
  

• Safety endpoint [ Time Frame: baseline (day 0) and day 28 ] [ Designated as safety issue: Yes ]
  Change in hemoglobin concentration
  
  

Following the rapid development of significant drug resistance of Plasmodium falciparum (Pf) to chloroquine and then sulfadoxine-pyrimethamine, artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Ethiopia in 2004. According to the current national malaria diagnosis and treatment guidelines updated in 2012, first-line treatment for uncomplicated P. falciparum infection is AL. First-line treatment for Plasmodium vivax (Pv) is chloroquine (CQ) alone in malarious areas and with primaquine in non-malarious areas at health center and hospital level. WHO recommends treatment of Pv with CQ or an artemisinin-based combination therapy (ACT) in combination with primaquine. For all clinical infection without laboratory confirmation, AL is the first-line treatment since AL is effective against both Pf and Pv. Thus, in Ethiopia, where treatment for malaria without laboratory confirmation occurs frequently, Pv is often treated with AL as the standard of care. Similarly, the recommended drug for mixed infection with Pf and Pv is AL. Now with wide-spread use of AL and CQ and with evidence that malaria laboratory testing is occurring in about half of those suspected with clinical evidence of malaria infection, the investigators propose to conduct an antimalarial efficacy study to monitor the effectiveness of these therapies in Ethiopia and to determine how efficacious these drugs remain for Pv. In addition, with high rates of relapse with P. vivax infection, the efficacy and safety of co-administering primaquine will be assessed. This information will inform future policy changes with respect to appropriate antimalarial strategies.