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Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial

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Show simple item record Bassat, Q. Mulenga, M. Tinto, H. Piola, P. Borrmann, S. Menéndez, C. Nambozi, M. Valéa, I. Nabasumba, C. Sasi, P. Bacchieri, A. Corsi, M. Ubben, D. Talisuna, A. D'Alessandro, U. 2009-12-16T13:53:05Z 2009-12-16T13:53:05Z 2009
dc.identifier.issn 1932-6203
dc.identifier.other ITG-P14B
dc.identifier.other ITG-PLA
dc.identifier.other PARAS
dc.identifier.other U-MALAR
dc.identifier.other ELECTRONIC
dc.identifier.other DOI
dc.identifier.other UPD17
dc.identifier.other FTA
dc.identifier.other ABSTRACT
dc.description.abstract BACKGROUND: Artemisinin combination therapies (ACTs) are currently the preferred option for treating uncomplicated malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising fixed-dose ACT with limited information on its safety and efficacy in African children. METHODOLOGY/PRINCIPAL FINDINGS: The non-inferiority of DHA-PQP versus artemether-lumefantrine (AL) in children 6-59 months old with uncomplicated P. falciparum malaria was tested in five African countries (Burkina Faso, Kenya, Mozambique, Uganda and Zambia). Patients were randomised (2:1) to receive either DHA-PQP or AL. Non-inferiority was assessed using a margin of -5% for the lower limit of the one-sided 97.5% confidence interval on the treatment difference (DHA-PQP vs. AL) of the day 28 polymerase chain reaction (PCR) corrected cure rate. Efficacy analysis was performed in several populations, and two of them are presented here: intention-to-treat (ITT) and enlarged per-protocol (ePP). 1553 children were randomised, 1039 receiving DHA-PQP and 514 AL. The PCR-corrected day 28 cure rate was 90.4% (ITT) and 94.7% (ePP) in the DHA-PQP group, and 90.0% (ITT) and 95.3% (ePP) in the AL group. The lower limits of the one-sided 97.5% CI of the difference between the two treatments were -2.80% and -2.96%, in the ITT and ePP populations, respectively. In the ITT population, the Kaplan-Meier estimate of the proportion of new infections up to Day 42 was 13.55% (95% CI: 11.35%-15.76%) for DHA-PQP vs 24.00% (95% CI: 20.11%-27.88%) for AL (p<0.0001). CONCLUSIONS/SIGNIFICANCE: DHA-PQP is as efficacious as AL in treating uncomplicated malaria in African children from different endemicity settings, and shows a comparable safety profile. The occurrence of new infections within the 42-day follow up was significantly lower in the DHA-PQP group, indicating a longer post-treatment prophylactic effect. TRIAL REGISTRATION: ISRCTN16263443. en
dc.language English en
dc.subject Protozoal diseases en
dc.subject Malaria en
dc.subject Plasmodium falciparum en
dc.subject Children en
dc.subject Drug therapy en
dc.subject Antimalarials en
dc.subject Artemisinin combination therapies (ACT) en
dc.subject Dihydroartemisinin-piperaquine en
dc.subject Artemether-lumefantrine en
dc.subject Safety en
dc.subject Tolerability en
dc.subject Efficacy en
dc.subject Recurrence en
dc.subject Comparative study en
dc.subject Randomized non-inferiority trials en
dc.subject Africa en
dc.title Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial en
dc.type Article-E en
dc.citation.issue 11 en
dc.citation.jtitle PLoS ONE en
dc.citation.volume 4 en
dc.citation.pages 10 pp. en
dc.citation.jabbreviation PLoS ONE en

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