Abstract | BACKGROUND: METHODS: RESULTS: Between February 2010 and August 2016, 511 pregnant women with malaria (353 P. vivax, 142 P. falciparum, 15 co-infections, 1 Plasmodium malariae) were randomized to either DP (n=170), ASMQ (n=169) or AL+ (n=172) treatments. Successful malaria elimination efforts in the region resulted in premature termination of the trial. The majority of women had recurrent malaria (mainly P. vivax relapses, which are not prevented by these treatments). Recurrence-free proportions (95% confidence interval [95% CI]) for vivax malaria were 20.6% (5.1-43.4) for DP (n=125), 46.0% (30.9-60.0) for ASMQ (n=117) and 28.7% (10.0-50.8) for AL+ (n=126). DP and ASMQ provided longer recurrence-free intervals. PCR-corrected cure rates (95% CI) for falciparum malaria were 93.7% (81.6-97.9) for DP (n=49), 79.6% (66.1-88.1) for AMSQ (n=55) and 87.5% (74.3-94.2) for AL+ (n=50). Overall 65% (85/130) of P. falciparum infections had Pfkelch13 propeller mutations which increased over time and recrudescence occurred almost exclusively in them; risk ratio 9.42 (95% CI 1.30-68.29). Among the women with falciparum malaria, 24.0% (95% CI 16.8-33.6) had P. vivax parasitaemia within 4 months. Nausea, vomiting, dizziness and sleep disturbance were more frequent with ASMQ. Miscarriage, small-for-gestational-age and preterm birth did not differ significantly among the treatment groups, including first trimester exposures (n=46). CONCLUSIONS: DP was well tolerated and safe, and was the only drug providing satisfactory efficacy for P. falciparum-infected pregnant woman in this area of widespread artemisinin resistance. Vivax malaria recurrences are very common and warrant chloroquine prophylaxis after antimalarial treatment in this area. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01054248 , registered on 22 January 2010.
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Authors | Makoto Saito, Verena I Carrara, Mary Ellen Gilder, Aung Myat Min, Nay Win Tun, Mupawjay Pimanpanarak, Jacher Viladpai-Nguen, Moo Kho Paw, Warat Haohankhunnatham, Kamonchanok Konghahong, Aung Pyae Phyo, Cindy Chu, Claudia Turner, Sue J Lee, Jureeporn Duanguppama, Mallika Imwong, Germana Bancone, Stephane Proux, Pratap Singhasivanon, Nicholas J White, François Nosten, Rose McGready |
Journal | BMC medicine
(BMC Med)
Vol. 19
Issue 1
Pg. 132
(06 10 2021)
ISSN: 1741-7015 [Electronic] England |
PMID | 34107963
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antimalarials
- Artemether, Lumefantrine Drug Combination
- Artemisinins
- Quinolines
- Artesunate
- artenimol
- piperaquine
- Artemether
- Mefloquine
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Topics |
- Antimalarials
(therapeutic use)
- Artemether
(therapeutic use)
- Artemether, Lumefantrine Drug Combination
(therapeutic use)
- Artemisinins
(therapeutic use)
- Artesunate
(therapeutic use)
- Drug Therapy, Combination
- Female
- Humans
- Infant, Newborn
- Malaria
(drug therapy)
- Malaria, Falciparum
(drug therapy, epidemiology)
- Mefloquine
(therapeutic use)
- Myanmar
- Pregnancy
- Premature Birth
- Quinolines
(adverse effects)
- Thailand
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