@article{fdi:010062613,
  title = {{I}ntermittent preventive treatment of malaria in pregnancy with mefloquine in {HIV}-negative women : a multicentre randomized controlled trial},
  author = {{G}onzalez, {R}. and {M}ombo-{N}goma, {G}. and {O}uedraogo, {S}. and {K}akolwa, {M}. {A}. and {A}bdulla, {S}. and {A}ccrombessi, {M}. and {A}ponte, {J}. {J}. and {A}kerey-{D}iop, {D}. and {B}asra, {A}. and {B}riand, {V}al{\'e}rie and {C}apan, {M}. and {C}ot, {M}ichel and {K}abanywanyi, {A}. {M}. and {K}leine, {C}. and {K}remsner, {P}. {G}. and {M}acete, {E}. and {M}ackanga, {J}. {R}. and {M}assougbodgi, {A}. and {M}ayor, {A}. and {N}hacolo, {A}. and {P}ahlavan, {G}. and {R}amharter, {M}. and {R}uperez, {M}. and {S}evene, {E}. and {V}ala, {A}. and {Z}oleko-{M}anego, {R}. and {M}enendez, {C}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {I}ntermittent preventive treatment in pregnancy ({IPT}p) with sulfadoxine-pyrimethamine ({SP}) is recommended by {WHO} to prevent malaria in {A}frican pregnant women. {T}he spread of {SP} parasite resistance has raised concerns regarding long-term use for {IPT}. {M}efloquine ({MQ}) is the most promising of available alternatives to {SP} based on safety profile, long half-life, and high efficacy in {A}frica. {W}e evaluated the safety and efficacy of {MQ} for {IPT}p compared to those of {SP} in {HIV}-negative women. {M}ethods and {F}indings {A} total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in {B}enin, {G}abon, {M}ozambique, and {T}anzania comparing two-dose {MQ} or {SP} for {IPT}p and {MQ} tolerability of two different regimens. {T}he 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. {T}here 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). {W}omen 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). {T}here were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. {T}olerability was poorer in the two {MQ} groups compared to {SP}. {T}he 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. {T}he open-label design is a limitation of the study that affects mainly the safety assessment. {C}onclusions {W}omen taking {MQ} {IPT}p (15 mg/kg) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking {SP} {IPT}p. {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. {T}hese results do not support a change in the current {IPT}p policy. {T}rial registration {C}linical{T}rials.gov {NCT} 00811421; {P}an {A}frican {C}linical {T}rials {R}egistry {PACTR} 2010020001429343},
  keywords = {{BENIN} ; {GABON} ; {MOZAMBIQUE} ; {TANZANIE}},
  booktitle = {},
  journal = {{P}los {M}edicine},
  volume = {11},
  numero = {9},
  pages = {art. e1001733 [17 ]},
  ISSN = {1549-1676},
  year = {2014},
  DOI = {10.1371/journal.pmed.1001733},
  URL = {https://www.documentation.ird.fr/hor/fdi:010062613},
}