Abstract
BackgroundThe Lao Government changed the national policy for uncomplicated Plasmodium falciparum malaria from chloroquine to artemether-lumefantrine (AL) in 2005. Since then, no information on AL efficacy has been reported. With evidence of resistance to artemisinin derivatives in adjacent Cambodia, there has been a concern as to AL efficacy. Monitoring of AL efficacy would help the Lao Government to make decisions on appropriate malaria treatment.MethodsThe efficacy of a three-day, twice daily oral artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Xepon District, Savannakhet Province, southern Laos was studied over 42 days follow-up. This was part of a trial of thiamin supplementation in falciparum malaria.ResultsOf 630 patients with P. falciparum enrolled in the trial of thiamin treatment, 549 (87%, 357 children ≤15 years and 192 adults) were included in this study. The per protocol 42-day cure rates were 97% (524/541) [96% (337/352) for children and 99% (187/189) for adults, p = 0.042]. By conventional intention-to-treat analysis, the 42-day cure rates adjusted for re-infection, were 97% (532/549) [96% (342/357) in children and 99% (190/192) in adults, p = 0.042]. The proportion of patients who remained parasitaemic at day 1 after treatment was significantly higher in children [33% (116/356)] compared to adults [15% (28/192)] (p < 0.001) and only one adult patient had detectable parasitaemia on day 2. There were no serious adverse events. Potential side effects after treatment were reported more commonly in adults (32%) compared to children (15%) (p < 0.001). Patients with recrudescent infections were significantly younger, had longer mean time to fever clearance, and had longer median time to parasite clearance compared to those who were cured.ConclusionsThe current nationally-recommended anti-malarial treatment (artemether-lumefantrine) remains highly efficacious for the treatment of uncomplicated falciparum malaria five years after introduction in Laos. Regular monitoring is required in case artemisinin-resistant P. falciparum parasites should appear.Trial registrationISRCTN85411059.
Highlights
The Lao Government changed the national policy for uncomplicated Plasmodium falciparum malaria from chloroquine to artemether-lumefantrine (AL) in 2005
Background the incidence of Plasmodium falciparum malaria has declined recently in northern and central Lao PDR (Laos), malaria remains an important cause of morbidity and mortality in southern Laos, with an estimated incidence of 4.7 to 23.5/1,000 population between 20062008 [1,2,3]
The clinical trial of thiamin supplementation in falciparum malaria conducted among patients with P. falciparum malaria receiving anti-malarial therapy according to national guidelines, was an exploratory, double-blind, parallel group, placebo-controlled, randomized, superiority trial to compare the frequency of clinical adverse effects and thiamin status, during 42 days follow up, of either daily oral thiamin supplementation ([oral thiamin (5 mg tablet) (Olan-Kemed Co.Ltd, Bangkok, Thailand)] 10 mg immediately after anti-malarial drugs, followed by 10 mg daily for 7 days followed by 5 mg daily until day 42), or an identical placebo
Summary
The Lao Government changed the national policy for uncomplicated Plasmodium falciparum malaria from chloroquine to artemether-lumefantrine (AL) in 2005. The change of the Lao Government national treatment policy for uncomplicated falciparum malaria from chloroquine to artemether-lumefantrine in 2005 is likely to have contributed substantially to the reduction in the incidence of malaria in northern and central Laos. This change was prompted by high levels of P. falciparum resistance to chloroquine (CQ) and sulphadoxine-pyrimethamine (SP) [4,5,6,7,8]. AL has to be taken twice a day, and should be taken with fats [16,17,18,19,20] which may compromise adherence and efficacy respectively, so there is concern that AL efficacy could decline, if protection from the coadministered artemether is compromised by emerging resistance
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