Clinical trial of chloroquine weekly or as IPT to prevent malaria in pregnancy in

说明（由申请人提供）：抗疟疾药物通常用于预防怀孕期间的疟疾，因为感染可能威胁到母亲及其未出生婴儿的健康。我们建议进行一项随机对照试验，比较两种非常不同的药物干预策略，这两种策略都被证明可以预防妊娠期疟疾的后遗症：连续每周预防和间歇性预防治疗（IPT）。在没有明显耐药性的情况下，这些策略从未在使用同一药物的直接比较试验中进行过评估。我们在马拉维有一个独特的机会来比较这些战略，我们最近发现，在氯喹因耐药性高而被停用12年后，对氯喹敏感的寄生虫占主导地位，氯喹再次成为治疗疟疾的有效药物。氯喹可在怀孕期间作为每周预防或间歇预防治疗使用。在本研究中，我们的目的是：(1)比较氯喹作为每周预防与IPT在预防妊娠相关疟疾及其后遗症方面的疗效；(2)比较这些治疗策略对抗疟药物耐药性的影响；(3)评估疟疾感染的来源和时间对妊娠期疟疾后遗症的影响。

DESCRIPTION (provided by applicant): Antimalarial drugs are frequently used to prevent malaria in pregnancy, when infection can threaten the health of mothers and their unborn babies. We propose to conduct a randomized controlled trial comparing two very different drug intervention strategies that have both been shown to prevent the sequelae of malaria in pregnancy: continuous weekly prophylaxis and intermittent preventive treatment (IPT). These strategies have never been assessed using the same drug in a direct comparative trial in the absence of significant drug resistance. We have a unique opportunity to compare these strategies in Malawi, where we recently discovered that twelve years after chloroquine was withdrawn due to high rates of resistance, chloroquine-susceptible parasites predominate and chloroquine is once again an effective agent to treat malaria. Chloroquine can be used during pregnancy as weekly prophylaxis or intermittent preventive therapy. In the proposed study, our aims are (1) to compare the efficacy of chloroquine as weekly prophylaxis vs. IPT in the prevention of pregnancy-associated malaria and its sequelae, (2) to compare the effect of these treatment strategies on antimalarial drug resistance and (3) to assess the impact of the origin and timing of malaria infections the sequelae of malaria in pregnancy. RELEVANCE: This study will provide important information for the future use of antimalarial medication and other interventions for the prevention of malaria in pregnancy. We will examine how and when to prevent pregnancy-associated malaria to protect mothers and their newborns and also avoid the spread of drug resistance.