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Four artemisinin-based treatments in African pregnant women with malaria

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dc.contributor.author Pekyi, D. en_US
dc.contributor.author Ampromfi, A. A. en_US
dc.contributor.author Tinto, H. en_US
dc.contributor.author Traore-Coulibaly, M. en_US
dc.contributor.author Tahita, M. C. en_US
dc.contributor.author Valea, I. en_US
dc.contributor.author Mwapasa, V. en_US
dc.contributor.author Kalilani-Phiri, L. en_US
dc.contributor.author Kalanda, G. en_US
dc.contributor.author Madanitsa, M. en_US
dc.contributor.author Ravinetto, R. en_US
dc.contributor.author Mutabingwa, T. en_US
dc.contributor.author Gbekor, P. en_US
dc.contributor.author Tagbor, H. en_US
dc.contributor.author Antwi, G. en_US
dc.contributor.author Menten, J. en_US
dc.contributor.author De Crop, M. en_US
dc.contributor.author Claeys, Y. en_US
dc.contributor.author Schurmans, C. en_US
dc.contributor.author Van Overmeir, C. en_US
dc.contributor.author Thriemer, K. en_US
dc.contributor.author Van geertruyden, J. P. en_US
dc.contributor.author D'Alessandro, U. en_US
dc.contributor.author Nambozi, M. en_US
dc.contributor.author Mulenga, M. en_US
dc.contributor.author Hachizovu, S. en_US
dc.contributor.author Kabuya, J. B. en_US
dc.contributor.author Mulenga, J. en_US
dc.contributor.author PREGACT Study Group en_US
dc.date.accessioned 2017-12-18T12:56:05Z
dc.date.available 2017-12-18T12:56:05Z
dc.date.issued 2016 en_US
dc.identifier.issn 1995-7262 en_US
dc.identifier.other http://lib.itg.be/pdf/itg/2016/2016mmjo0139.pdf en_US
dc.identifier.other 29 en_US
dc.identifier.other ITG-C11A; ITG-C16A; ITG-C17A; ITG-C18A; ITG-H20B; ITG-H23A; MULTI; DCS; U-CTU; DPH; U-ECMAL; INTER; U-QUAL; JIF; PDF; PMC; Abstract; DSPACE64 en_US
dc.identifier.uri http://hdl.handle.net/10390/9851
dc.description.abstract BACKGROUND: Information regarding the safety and efficacy of artemisinin combination treatments for malaria in pregnant women is limited, particularly among women who live in sub-Saharan Africa. METHODS: We conducted a multicenter, randomized, open-label trial of treatments for malaria in pregnant women in four African countries. A total of 3428 pregnant women in the second or third trimester who had falciparum malaria (at any parasite density and regardless of symptoms) were treated with artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate, or dihydroartemisinin-piperaquine. The primary end points were the polymerase-chain-reaction (PCR)-adjusted cure rates (i.e., cure of the original infection; new infections during follow-up were not considered to be treatment failures) at day 63 and safety outcomes. RESULTS: The PCR-adjusted cure rates in the per-protocol analysis were 94.8% in the artemether-lumefantrine group, 98.5% in the amodiaquine-artesunate group, 99.2% in the dihydroartemisinin-piperaquine group, and 96.8% in the mefloquine-artesunate group; the PCR-adjusted cure rates in the intention-to-treat analysis were 94.2%, 96.9%, 98.0%, and 95.5%, respectively. There was no significant difference among the amodiaquine-artesunate group, dihydroartemisinin-piperaquine group, and the mefloquine-artesunate group. The cure rate in the artemether-lumefantrine group was significantly lower than that in the other three groups, although the absolute difference was within the 5-percentage-point margin for equivalence. The unadjusted cure rates, used as a measure of the post-treatment prophylactic effect, were significantly lower in the artemether-lumefantrine group (52.5%) than in groups that received amodiaquine-artesunate (82.3%), dihydroartemisinin-piperaquine (86.9%), or mefloquine-artesunate (73.8%). No significant difference in the rate of serious adverse events and in birth outcomes was found among the treatment groups. Drug-related adverse events such as asthenia, poor appetite, dizziness, nausea, and vomiting occurred significantly more frequently in the mefloquine-artesunate group (50.6%) and the amodiaquine-artesunate group (48.5%) than in the dihydroartemisinin-piperaquine group (20.6%) and the artemether-lumefantrine group (11.5%) (P<0.001 for comparison among the four groups). CONCLUSIONS: Artemether-lumefantrine was associated with the fewest adverse effects and with acceptable cure rates but provided the shortest posttreatment prophylaxis, whereas dihydroartemisinin-piperaquine had the best efficacy and an acceptable safety profile. (Funded by the European and Developing Countries Clinical Trials Partnership and others; ClinicalTrials.gov number, NCT00852423.). en_US
dc.language English en_US
dc.publisher Malawi Medical Journal en_US
dc.relation.uri http://www.ncbi.nlm.nih.gov/pubmed/27895848 en_US
dc.subject Malaria en_US
dc.subject Protozoal diseases en_US
dc.subject Pregnancy en_US
dc.subject Women en_US
dc.subject Treatment en_US
dc.subject Artemisinin combination therapies (ACT) en_US
dc.subject ACT en_US
dc.subject PREGACT en_US
dc.subject Africa-General en_US
dc.title Four artemisinin-based treatments in African pregnant women with malaria en_US
dc.type Article en_US
dc.citation.issue 3 en_US
dc.citation.volume 28 en_US
dc.citation.pages 139 en_US
dc.citation.abbreviation Malawi Med J en_US


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