Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial

Sagara, Issaka; Rulisa, Stephen; Mbacham, Wilfred Fon; Adam, Ishag; Sissoko, Kourane; Maiga, Hamma; Traoré, Oumou; Dara, Niawanlou; Dicko, Yahia; Dicko, Alassane; Djimdé, Abdoulaye; Jansen, F. H.; Doumbo, Ogobara K.

doi:10.1186/1475-2875-8-63

Cited by 51 publications

(49 citation statements)

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“…Consistent with a recent study, the present study showed that P. vivax is a health problem and that its ratio to P. falciparum has increased [8]. Previous studies showed that AL had a high efficacy (98.7%) for treatment of uncomplicated P. falciparum malaria in eastern Sudan as well as other regions of the country [20,21]. Interestingly, in neighbouring Ethiopia, a higher failure rate was observed (19%) when AL was compared with chloroquine for treatment of uncomplicated P. vivax malaria [4].…”

Section: Discussionsupporting

confidence: 90%

Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan

Abdallah

Ali

Bakri

et al. 2012

Malar J

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BackgroundArtemisinin-based combination therapy (ACT) is the treatment of choice for uncomplicated Plasmodium falciparum malaria in most areas of the world, where malaria is endemic, including Sudan. However, few published data are available on the use of ACT for treatment of P. vivax malaria.MethodsThis study was conducted at a health centre in Kassala, eastern Sudan, from October to December 2011. Patients with uncomplicated P. vivax malaria received artemether-lumefantrine (AL) tablets (containing 20mg artemether and 120 mg lumefantrine) and were monitored for 28 days.ResultsOut of the 43 cases enrolled in this study, 38 completed the 28-day follow-up. Their mean age was 25.1 years (SD: 1.5). On day 3 following AL treatment, all of the patients were afebrile and aparasitaemic. By day 28, all 38 patients exhibited adequate clinical and parasitological responses to AL treatment. The cure rate was 100% and 88.4% for the per protocol analysis andfor the intention to treat analysis, respectively. Mild adverse effects (nausea, vomiting, abdominal pain, dizziness and/or rash) that resolved spontaneously were observed in four (10.5%) of the patients.ConclusionAL combination therapy was fully effective for treatment of P. vivax malaria in the study in eastern Sudan.Trial registrationTrial. Gov: NCT01625871

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Section: Discussionsupporting

confidence: 90%

Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan

Abdallah

Ali

Bakri

et al. 2012

Malar J

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“…These results are comparable to data reported from previous studies. [27][28][29][30][31][32] SP is recommended in IPTp and has been used in other interventions such as SMC in Africa. [23][24][25][26] There is a concern about the rapid emergence of SP resistance.…”

Section: Discussionmentioning

confidence: 99%

In Vivo Efficacy and Parasite Clearance of Artesunate + Sulfadoxine–Pyrimethamine Versus Artemether–Lumefantrine in Mali

Niaré¹,

Dara²,

Sagara³

et al. 2016

The American Society of Tropical Medicine and Hygiene

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Abstract. Although artemisinin resistance has yet to be reported in Africa, surveillance of the efficacy of artemisininbased combination therapies (ACTs) is warranted. Here, the efficacy of artesunate + sulfadoxine-pyrimethamine (AS+SP) and artemether-lumefantrine (AL) was evaluated in Mali. Randomized open-label comparative in vivo assay of AS+SP versus AL were carried out using the 28-day follow-up World Health Organization protocol. Patients with uncomplicated falciparum malaria and at least 6 months of age were recruited between October 2010 and January 2014. A subset of these patients was selected to measure Plasmodium falciparum clearance time. Polymerase chain reactioncorrected adequate clinical and parasitological responses were 100% for AS+SP and 98.2% for AL with no significant difference (P = 0.06). The reinfection rates were comparable (P = 0.63) with 8.0% for AS+SP and 12.6% for AL. Individuals under 8 years were more susceptible to treatment failure (relative risk = 1.9; 95% confidence interval = 1.2, 3.3). Median parasite clearance half-life was 1.7 hours (interquartile range [IQR] = 1.3-2.2) for AS+SP and 1.9 hours (IQR = 1.5-2.5) for AL with no statistically significant difference (P = 0.24). Efficacy of AS+SP and AL was high. This study provides baseline information on parasite clearance half-lives after ACT treatment, particularly AS+SP, in Mali.

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“…In fact, this product is easy to use, safe, and has previously demonstrated high efficacy in several endemic areas whether it is taken under a 24- or 48- hour regimen [3-5]. Previously offered as a co-blistered drug [6,7], the AS + SMP combination is now available as a FDC, which can easily be taken by malaria patients (three tablets only).…”

Section: Introductionmentioning

confidence: 99%

An open randomized clinical trial in comparing two artesunate-based combination treatments on Plasmodium falciparum malaria in Nigerian children: artesunate/sulphamethoxypyrazine/pyrimethamine (fixed dose over 24 hours) versus artesunate/amodiaquine (fixed dose over 48 hours)

Ayede

Falade

Sowunmi

et al. 2010

Malar J

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BackgroundSeveral studies have demonstrated the efficacy of artemisinin-combination therapy (ACT) across malaria zones of the world. Fixed dose ACT with shorter courses and fewer tablets may be key determinants to ease of administration and compliance.MethodsChildren aged one year to 13 years presenting with uncomplicated Plasmodium falciparum malaria were recruited in Ibadan, south-western Nigeria. A total of 250 children each were randomly assigned to receive three doses of artesunate/sulphamethoxypyrazine/pyrimethamine (AS + SMP) (12 hourly doses over 24 hours) or three doses of artesunate/amodiaquine (AS + AQ) (daily doses over 48 hours). Efficacy and safety of the two drugs were assessed using a 28-day follow-up and the primary outcome was PCR- corrected parasitological cure rate and clinical response.ResultsThere were two (0.4%) early treatment failures, one in each treatment arm. The PCR corrected cure rates for day 28 was 97.9% in the AS + AQ arm and 95.6% in the AS + SMP arm (p = 0.15). The re-infection rate was 1.7% in the AS + AQ arm and 5.7% in the AS + SMP arm (p = 0.021). The fever clearance time was similar in the two treatment groups: 1 - 2 days for both AS + SMP and AS + AQ (p = 0.271). The parasite clearance time was also similar in the two treatment groups with 1 - 7 days for AS + SMP and 1 - 4 days for AS + AQ (p = 0.941). The proportion of children with gametocytes over the follow-up period was similar in both treatment groups. Serious Adverse Events were not reported in any of the patients and in all children, laboratory values (packed cell volume, liver enzymes, bilirubin) remained within normal levels during the follow-up period but the packed cell volume was significantly lower in the AS + SMP group.ConclusionsThis study demonstrates that AS + SMP FDC given as three doses over 24 hours (12-hour intervals) has similar efficacy as AS + AQ FDC given as three doses over 48 hours (24-hour interval) for the treatment of uncomplicated Plasmodium falciparum malaria in children in Nigeria. Both drugs also proved to be safe. Therefore, AS + SMP could be an alternative to currently recommended first-line ACT with continuous resistance surveillance.

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Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial

Cited by 51 publications

References 29 publications

Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan

Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan

In Vivo Efficacy and Parasite Clearance of Artesunate + Sulfadoxine–Pyrimethamine Versus Artemether–Lumefantrine in Mali

An open randomized clinical trial in comparing two artesunate-based combination treatments on Plasmodium falciparum malaria in Nigerian children: artesunate/sulphamethoxypyrazine/pyrimethamine (fixed dose over 24 hours) versus artesunate/amodiaquine (fixed dose over 48 hours)

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