5-Day nonobserved artesunate monotherapy for treating uncomplicated Falciparum malaria in young Gabonese children

Medical Research Unit, Albert Schweitzer Hospital Lambaréné, Gabon.
The American journal of tropical medicine and hygiene (Impact Factor: 2.7). 11/2005; 73(4):705-9.
Source: PubMed


Despite different recommendations from WHO and national authorities, artesunate monotherapy is increasingly used for treating African children with malaria. A 5-day course of oral artesunate (first day: 4 mg/kg body weight, observed intake; and 2 mg/kg body weight on the following days with nonobserved drug intake) yielded a PCR-corrected Day 28 cure rate of 90% (45 of 50 patients; CI 78-97%) in Gabonese children aged between 2 and 18 months. Artesunate was well tolerated, and no severe adverse events were reported.

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Available from: Norbert Georg Schwarz
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    • "Artesunate is the most widely used artemisinin derivative (Zhang et al., 2001) and forms the backbone of many of the available artemisinin based combination therapies in falciparum Malaria. Artemisinin derivatives have a very rapid onset of action, resulting in rapid parasite clearance and also being effective against parasites that are resistant to other anti-Malarial drugs (Schwarz et al., 2005), and is used in both uncomplicated and severe Malaria. Both Lamivudine and Artesunate often find use in non disease states when used either for post exposure prophylaxis, in the case of Lamivudine, or presumptive treatment in Malaria with Artesunate. "
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    ABSTRACT: HIV-Malaria co morbidity frequently requires the co administration of Lamivudine and Artesunate, in Malaria endemic areas where HIV is also a problem. This situation is a frequent occurrence in developing countries of the tropics, like Nigeria where the burden of Malaria and HIV is heavy. The co administration of these drugs may result in interactions with possible physiologic and/or therapeutic consequences. This study investigated the effect of Lamivudine-Artesunate co administration on body weight, relative organ weight and glucose tolerance in healthy and diseased (Plasmodium berghei infected and cyclophosphamide immunosuppressed) wistar rats. Animals received a cumulative 21 day treatment with Lamivudine (20 mg/kg) and/or 7 day Artesunate (10 mg/kg), with healthy or disease controls. Results showed that organ weights and body weights were not affected. Oral glucose was however affected in the combination and Artesunate groups in both disease and healthy rats. The study shows that glucose tolerance is altered with Lamivudine-Artesunate co administration, and may be beneficial, as hypoglycaemia is often a complication of Malaria therapy.
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    • "The only previous studies assessing efficacy of SP were conducted in Franceville (Haut-Ogooué province) reporting a good efficacy of SP with clinical resistance rates below 10% [15]. A clinical trial testing the efficacy of AS monotherapy conducted in Lambarané showed an excellent clinical efficacy with a PCR-corrected 28-day cure rate of 90% [16]. "
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    ABSTRACT: In Gabon, following the adoption of amodiaquine/artesunate combination (AQ/AS) as first-line treatment of malaria and of sulphadoxine/pyrimethamine (SP) for preventive intermittent treatment of pregnant women, a clinical trial of SP versus AQ was conducted in a sub-urban area. This is the first study carried out in Gabon following the WHO guidelines. A random comparison of the efficacy of AQ (10 mg/kg/day x 3 d) and a single dose of SP (25 mg/kg of sulphadoxine/1.25 mg/kg of pyrimethamine) was performed in children under five years of age, with uncomplicated falciparum malaria, using the 28-day WHO therapeutic efficacy test. In addition, molecular genotyping was performed to distinguish recrudescence from reinfection and to determine the frequency of the dhps K540E mutation, as a molecular marker to predict SP-treatment failure. The day-28 PCR-adjusted treatment failures for SP and AQ were 11.6% (8/69; 95% IC: 5.5-22.1) and 28.2% (20/71; 95% CI: 17.7-38.7), respectively This indicated that SP was significantly superior to AQ (P = 0.019) in the treatment of uncomplicated childhood malaria and for preventing recurrent infections. Both treatments were safe and well-tolerated, with no serious adverse reactions recorded. The dhps K540E mutation was not found among the 76 parasite isolates tested. The level of AQ-resistance observed in the present study may compromise efficacy and duration of use of the AQ/AS combination, the new first-line malaria treatment. Gabonese policy-makers need to plan country-wide and close surveillance of AQ/AS efficacy to determine whether, and for how long, these new recommendations for the treatment of uncomplicated malaria remain valid.
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    • "There was no serious adverse event or death recorded. In the supervised group, two subjects were treated with the five-day artesunate monotherapy [29], because they vomited after a repeated dose of artesunate plus amodiaquine. Three subjects missed the second dose, one missed the third dose and 1 missed the second and third dose, while in the unsupervised group, two subjects were hospitalized for weakness. "
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    ABSTRACT: Artesunate-amodiaquine combination for the treatment of childhood malaria is one of the artemisinin combination therapies (ACTs) recommended by National authorities in many African countries today. Effectiveness data on this combination in young children is scarce. The effectiveness of three daily doses of artesunate plus amodiaquine combination given unsupervised (n = 32), compared with the efficacy when given under full supervision (n = 29) to children with falciparum malaria were assessed in an unrandomized study. 61 patients analysed revealed a PCR-corrected day-28 cure rate of 86 % (25 of 29 patients; CI 69-95 %) in the supervised group and 63 % (20 of 32 patients; CI 45-77 %) in the unsupervised group. The difference in outcome between both groups was statistically significant (p = 0.04). No severe adverse events were reported. The effectiveness of this short course regimen in young children with falciparum malaria could be augmented by increased adherence and improved formulation.
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