Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial.
<h4>Background</h4>Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is th...
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oai:doaj.org-article:224776a66dfe4a6191532a54a0e6bc0c2021-11-25T05:36:35ZIntermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial.1549-12771549-167610.1371/journal.pmed.1001733https://doaj.org/article/224776a66dfe4a6191532a54a0e6bc0c2014-09-01T00:00:00Zhttps://doi.org/10.1371/journal.pmed.1001733https://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women.<h4>Methods and findings</h4>A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1) SP, (2) single dose MQ (15 mg/kg), and (3) split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome) between groups (360/2,778 [13.0%]) for MQ group and 177/1,398 (12.7%) for SP group; risk ratio [RR], 1.02 (95% CI 0.86-1.22; p=0.80 in the ITT analysis). Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51-0.96]; p=0.03) and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85-0.99]; p=0.03), and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52-0.88]; p=0.004) and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78-0.95]; p=0.003). There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP. The most frequently reported related adverse events were dizziness (ranging from 33.9% to 35.5% after dose 1; and 16.0% to 20.8% after dose 2) and vomiting (30.2% to 31.7%, after dose 1 and 15.3% to 17.4% after dose 2) with similar proportions in the full and split MQ arms. The open-label design is a limitation of the study that affects mainly the safety assessment.<h4>Conclusions</h4>Women taking MQ IPTp (15 mg/kg) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking SP IPTp. MQ recipients had less clinical malaria than SP recipients, and the pregnancy outcomes and safety profile were similar. MQ had poorer tolerability even when splitting the dose over two days. These results do not support a change in the current IPTp policy.<h4>Trial registration</h4>ClinicalTrials.gov NCT 00811421; Pan African Clinical Trials Registry PACTR 2010020001429343 Please see later in the article for the Editors' Summary.Raquel GonzálezGhyslain Mombo-NgomaSmaïla OuédraogoMwaka A KakolwaSalim AbdullaManfred AccrombessiJohn J AponteDaisy Akerey-DiopArti BasraValérie BriandMeskure CapanMichel CotAbdunoor M KabanywanyiChristian KleinePeter G KremsnerEusebio MaceteJean-Rodolphe MackangaAchille MassougbodgiAlfredo MayorArsenio NhacoloGolbahar PahlavanMichael RamharterMaría RupérezEsperança SeveneAnifa ValaRella Zoleko-ManegoClara MenéndezPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 11, Iss 9, p e1001733 (2014) |
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Medicine R Raquel González Ghyslain Mombo-Ngoma Smaïla Ouédraogo Mwaka A Kakolwa Salim Abdulla Manfred Accrombessi John J Aponte Daisy Akerey-Diop Arti Basra Valérie Briand Meskure Capan Michel Cot Abdunoor M Kabanywanyi Christian Kleine Peter G Kremsner Eusebio Macete Jean-Rodolphe Mackanga Achille Massougbodgi Alfredo Mayor Arsenio Nhacolo Golbahar Pahlavan Michael Ramharter María Rupérez Esperança Sevene Anifa Vala Rella Zoleko-Manego Clara Menéndez Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. |
| description |
<h4>Background</h4>Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women.<h4>Methods and findings</h4>A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1) SP, (2) single dose MQ (15 mg/kg), and (3) split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome) between groups (360/2,778 [13.0%]) for MQ group and 177/1,398 (12.7%) for SP group; risk ratio [RR], 1.02 (95% CI 0.86-1.22; p=0.80 in the ITT analysis). Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51-0.96]; p=0.03) and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85-0.99]; p=0.03), and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52-0.88]; p=0.004) and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78-0.95]; p=0.003). There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP. The most frequently reported related adverse events were dizziness (ranging from 33.9% to 35.5% after dose 1; and 16.0% to 20.8% after dose 2) and vomiting (30.2% to 31.7%, after dose 1 and 15.3% to 17.4% after dose 2) with similar proportions in the full and split MQ arms. The open-label design is a limitation of the study that affects mainly the safety assessment.<h4>Conclusions</h4>Women taking MQ IPTp (15 mg/kg) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking SP IPTp. MQ recipients had less clinical malaria than SP recipients, and the pregnancy outcomes and safety profile were similar. MQ had poorer tolerability even when splitting the dose over two days. These results do not support a change in the current IPTp policy.<h4>Trial registration</h4>ClinicalTrials.gov NCT 00811421; Pan African Clinical Trials Registry PACTR 2010020001429343 Please see later in the article for the Editors' Summary. |
| format |
article |
| author |
Raquel González Ghyslain Mombo-Ngoma Smaïla Ouédraogo Mwaka A Kakolwa Salim Abdulla Manfred Accrombessi John J Aponte Daisy Akerey-Diop Arti Basra Valérie Briand Meskure Capan Michel Cot Abdunoor M Kabanywanyi Christian Kleine Peter G Kremsner Eusebio Macete Jean-Rodolphe Mackanga Achille Massougbodgi Alfredo Mayor Arsenio Nhacolo Golbahar Pahlavan Michael Ramharter María Rupérez Esperança Sevene Anifa Vala Rella Zoleko-Manego Clara Menéndez |
| author_facet |
Raquel González Ghyslain Mombo-Ngoma Smaïla Ouédraogo Mwaka A Kakolwa Salim Abdulla Manfred Accrombessi John J Aponte Daisy Akerey-Diop Arti Basra Valérie Briand Meskure Capan Michel Cot Abdunoor M Kabanywanyi Christian Kleine Peter G Kremsner Eusebio Macete Jean-Rodolphe Mackanga Achille Massougbodgi Alfredo Mayor Arsenio Nhacolo Golbahar Pahlavan Michael Ramharter María Rupérez Esperança Sevene Anifa Vala Rella Zoleko-Manego Clara Menéndez |
| author_sort |
Raquel González |
| title |
Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. |
| title_short |
Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. |
| title_full |
Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. |
| title_fullStr |
Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. |
| title_full_unstemmed |
Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. |
| title_sort |
intermittent preventive treatment of malaria in pregnancy with mefloquine in hiv-negative women: a multicentre randomized controlled trial. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2014 |
| url |
https://doaj.org/article/224776a66dfe4a6191532a54a0e6bc0c |
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