Abstract
BackgroundSystematic surveillance for resistant malaria shows high level of resistance of Plasmodium falciparum to sulfadoxine-pyrimethamine (SP) across eastern and southern parts of Africa. This study assessed in vivo SP efficacy after two years of use as an interim first-line drug in Tanzania, and determined the rates of treatment failures obtained after 14 and 28 days of follow-up.MethodsThe study was conducted in the Ipinda, Mlimba and Mkuranga health facilities in Tanzania. Children aged 6–59 months presenting with raised temperature associated exclusively with P. falciparum (1,000–100,000 parasites per μl) were treated with standard dose of SP. Treatment responses were classified according to the World Health Organization (WHO) definition as Adequate Clinical and Parasitological Response (ACPR), Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological Failure (LPF) on day 14 and day 28.ResultsOverall 196 (85.2%) of 230 patients had ACPR on day 14 but only 116 (50.9%) on day 28 (57.7% after excluding new infections by parasite genotyping). Altogether 21 (9.1%) and 13 (5.7%) of the 230 patients assessed up to day 14 and 39 (17.1%) and 55 (24.1%) of the 228 followed up to day 28 had clinical and parasitological failure, respectively.ConclusionThese findings indicate that SP has low therapeutic value in Tanzania. The recommendation of changing first line treatment to artemether + lumefantrine combination therapy from early next year is, therefore, highly justified. These findings further stress that, for long half-life drugs such as SP, establishment of cut-off points for policy change in high transmission areas should consider both clinical and parasitological responses beyond day 14.
Highlights
Systematic surveillance for resistant malaria shows high level of resistance of Plasmodium falciparum to sulfadoxine-pyrimethamine (SP) across eastern and southern parts of Africa
ACPR = Adequate Clinical and Parasitological Response; TF = Treatment failure, ETF = Early Treatment Failure, LCF = Late Clinical Failure; LPF = Late Parasitological Failure; CF = Clinical failure, n = Sample Size; TF = Treatment failure, FP = Lost to Follow-up, corr. = corrected out of 230 and 112 (49.1%) out of 228 patients had overall treatment failure by day 14 and 28, respectively
Baseline clinical trials with SP had been conducted throughout the country using the 14 day follow-up protocol, and indicated an average efficacy of 86% on day 14. These findings paved the way for the malaria treatment policy change [13] and SP is still used as first line antimalarial drug in Tanzania
Summary
Systematic surveillance for resistant malaria shows high level of resistance of Plasmodium falciparum to sulfadoxine-pyrimethamine (SP) across eastern and southern parts of Africa. This study assessed in vivo SP efficacy after two years of use as an interim first-line drug in Tanzania, and determined the rates of treatment failures obtained after 14 and 28 days of follow-up. There is controversy over the therapeutic life of sulfadoxine-pyrimethamine (SP) when used alone for the treatment of uncomplicated malaria in Africa. Experts do not all agree on which drug efficacy measurements more accurately predict usefulness of a drug in a community. Some (page number not for citation purposes). Malaria Journal 2005, 4:55 http://www.malariajournal.com/content/4/1/55 Site Means. Weight in kg(SD) Age in years (SD) Temperature in °C (SD) Hb1 in g/dl (SD) parasites/μl (SD).
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