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Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial

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dc.contributor.author Nambozi, M.
dc.contributor.author Mulenga, M.
dc.contributor.author Halidou, T.
dc.contributor.author Tagbor, H.
dc.contributor.author Mwapasa, V.
dc.contributor.author Phiri, L. K.
dc.contributor.author Kalanda, G.
dc.contributor.author Valea, I.
dc.contributor.author Traore, M.
dc.contributor.author Mwakazanga, D.
dc.contributor.author Claeys, Y.
dc.contributor.author Schurmans, C.
dc.contributor.author De Crop, M.
dc.contributor.author Menten, J.
dc.contributor.author Ravinetto, R.
dc.contributor.author Thriemer, K.
dc.contributor.author Van geertruyden, J. P.
dc.contributor.author Mutabingwa, T.
dc.contributor.author D'Alessandro, U.
dc.date.accessioned 2015-08-14T09:17:46Z
dc.date.available 2015-08-14T09:17:46Z
dc.date.issued 2015
dc.identifier.issn 1742-4755
dc.identifier.doi http://dx.doi.org/10.1186/1742-4755-12-5
dc.identifier.other ITG-C11B
dc.identifier.other ITG-C12B
dc.identifier.other ITG-C13B
dc.identifier.other ITG-C14A
dc.identifier.other ITG-C15A
dc.identifier.other ITG-B16A
dc.identifier.other ITG-HLA
dc.identifier.other MULTI-3
dc.identifier.other DCS
dc.identifier.other U-CTU
dc.identifier.other DPH
dc.identifier.other U-ECMAL
dc.identifier.other DBM
dc.identifier.other U-MALAR
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other URL
dc.identifier.other FTA
dc.identifier.other E-only
dc.identifier.other Abstract
dc.identifier.other UPD58
dc.identifier.uri http://hdl.handle.net/10390/8394
dc.description.abstract BACKGROUND: Asymptomatic and symptomatic malaria during pregnancy has consequences for both mother and her offspring. Unfortunately, there is insufficient information on the safety and efficacy of most antimalarials in pregnancy. Indeed, clinical trials assessing antimalarial treatments systematically exclude pregnancy for fear of teratogenicity and embryotoxicity. The little available information originates from South East Asia while in sub-Saharan Africa such information is still limited and needs to be provided. DESIGN: A Phase 3, non-inferiority, multicentre, randomized, open-label clinical trial on safety and efficacy of 4 ACT when administered during pregnancy was carried out in 4 African countries: Burkina Faso, Ghana, Malawi and Zambia. This is a four arm trial using a balanced incomplete block design. Pregnant women diagnosed with malaria are randomised to receive either amodiaquine-artesunate (AQ-AS), dihydroartemisinin-piperaquine (DHA-PQ), artemether-lumefantrine (AL), or mefloquine-artesunate (MQAS). They are actively followed up until day 63 post-treatment and then monthly until 4-6 weeks post-delivery. The offspring is visited at the time of the first birthday. The primary endpoint is treatment failure (PCR adjusted) at day 63 and safety profiles. Secondary endpoints included PCR unadjusted treatment failure up to day 63, gametocyte carriage, Hb changes, placenta malaria, mean birth weight and low birth weight. The primary statistical analysis will use the combined data from all 4 centres, with adjustment for any centre effects, using an additive model for the response rates. This will allow the assessment of all 6 possible pair-wise treatment comparisons using all available data. DISCUSSION: The strength of this trial is the involvement of several African countries, increasing the generalisability of the results. In addition, it assesses most ACTs currently available, determining their relative '-value-' compared to others. The balanced incomplete block design was chosen because using all 4-arms in each site would have increased complexity in terms of implementation. Excluding HIV-positive pregnant women on antiretroviral drugs may be seen as a limitation because of the possible interactions between antiretroviral and antimalarial treatments. Nevertheless, the results of this trial will provide the evidence base for the formulation of malaria treatment policy for pregnant women in sub-Saharan Africa. TRIAL REGISTRATION: NCT00852423. en_US
dc.language English en_US
dc.subject Protozoal diseases en_US
dc.subject Malaria en_US
dc.subject Plasmodium falciparum en_US
dc.subject Vectors en_US
dc.subject Mosquitoes en_US
dc.subject Anopheles en_US
dc.subject Artemisinin combination therapies (ACT) en_US
dc.subject Safety en_US
dc.subject Efficacy en_US
dc.subject Amodiaquine en_US
dc.subject Artesunate en_US
dc.subject Dihydroartemisinin-piperaquine en_US
dc.subject Artemether-lumefantrine en_US
dc.subject Mefloquine en_US
dc.subject Follow-up en_US
dc.subject Pregnancy en_US
dc.subject Randomized controlled trials en_US
dc.subject Clinical trials en_US
dc.subject Burkina Faso en_US
dc.subject Ghana en_US
dc.subject Africa, West en_US
dc.subject Malawi en_US
dc.subject Zambia en_US
dc.subject Africa, Southern en_US
dc.title Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial en_US
dc.type Article-E en_US
dc.citation.issue 5 en_US
dc.citation.jtitle Reproductive Health en_US
dc.citation.volume 12 en_US
dc.citation.pages 1-10 en_US
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/25592254
dc.identifier.url http://www.reproductive-health-journal.com/content/12/1/5
dc.citation.jabbreviation Reprod Health en_US


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