Safe Pregnancy by Infectious Disease Control in Kinshasa

金沙萨通过传染病控制实现安全怀孕

• 批准号: 7001031
• 负责人: Robert W. Ryder
• 金额: $ 8.16万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-26 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7001031
• 关键词: Africa; azithromycin; clinical research; clinical trial phase III; clinical trial phase IV; combination chemotherapy; communicable disease control; cooperative study; epidemiology; female; human pregnant subject; human therapy evaluation; isoniazid; malaria; microorganism disease chemotherapy; patient oriented research; pregnancy; pyrimethamine; rifamycins; sexually transmitted diseases; tuberculosis; vitamin B6; women' s health

DESCRIPTION (provided by applicant): Malaria, sexually transmitted infections (STIs), and tuberculosis (TB), are frequent in pregnant women (PW) in sub-Saharan Africa and are important preventable causes of poor birth outcomes and maternal morbidity and mortality. Many PW in Africa seek antenatal care (ANC) but do not receive appropriate care for these infections, although presumptive therapy (PT) with antibiotics or antimalarials and preventive therapy for TB can be effective. The antenatal visit thus represents a "missed opportunity" to improve maternal and infant health in resource-poor settings. We propose to develop two new antenatal interventions against these infections that can be widely implemented in the region. First, we will evaluate PT with azithromycin (AZM) in high-risk PW. AZM is effective against bacterial STIs; however cost-effective, practical PT regimens need to be identified. AZM also has antimalarial activity; by combining AZM with sulfadoxine-pyrimethamine (SP; standard-of-care PT for malaria), we hope to improve effectiveness and delay the onset of SP-resistant malaria. Second, we will test the safety of, and compliance with, a short-course regimen for latent TB infection in HIV (+) PW. We propose to work in two large antenatal care clinics in Kinshasa, Democratic Republic of Congo where we are currently offering antenatal HIV screening and treatment. At these clinics, our team will concurrently conduct two randomized, placebo-controlled clinical trials: (1) a four-arm trial to determine the efficacy of presumptive AZM (2 g) treatment taken by high-risk HIV (-) PW in the second trimester, third trimester, neither or both times (with all groups receiving SP); and (2) a separate two-arm trial in HIV (+), TB-infected PW to compare the safety of (and compliance to) the standard regimen of 9 months of isoniazid 300 mg/d with a short course regimen of 3 months of isoniazid (300 mg/d) plus rifampin (600 mg/d) for latent M. tb infection. This project is one of the first attempts to develop an integrated, practical approach to managing highly prevalent malaria, STIs, and TB in PW in resource-poor Africa. It will build on a productive history of collaboration between investigators in the USA and Kinshasa, especially Projet SIDA, where large longitudinal cohort studies in PW have been successful. It will also build upon, and augment, a burgeoning, multidisciplinary research and training program at the Kinshasa School of Public Health.

描述(申请人提供)：疟疾、性传播感染(STI)和结核病(TB)在撒哈拉以南非洲的孕妇(PW)中很常见，是导致不良生育结果和孕产妇发病率和死亡率的重要可预防原因。非洲的许多妇女寻求产前护理(ANC)，但没有得到这些感染的适当护理，尽管使用抗生素或抗疟疾药物的推定疗法(PT)和结核病的预防性治疗可能是有效的。因此，产前检查代表着在资源匮乏的情况下改善孕产妇和婴儿健康的“错失机会”。 我们建议开发两种针对这些感染的新的产前干预措施，可以在该地区广泛实施。首先，我们将评估使用阿奇霉素(Azm)治疗高危PW的PT。AZM对细菌性传播感染有效；然而，需要确定具有成本效益的、实用的PT方案。AZM还具有抗疟疾活性；通过将AZM与磺胺多辛-乙胺(SP；治疗疟疾的标准治疗PT)相结合，我们希望提高疗效并推迟耐SP疟疾的发生。其次，我们将测试HIV(+)PW中潜伏性结核病感染的短期方案的安全性和依从性。 我们计划在刚果民主共和国金沙萨的两家大型产前护理诊所工作，目前我们在那里提供产前艾滋病毒筛查和治疗。在这些诊所，我们的团队将同时进行两个随机、安慰剂对照的临床试验：(1)一项四臂试验，以确定高危HIV(-)PW在第二个三个月或第三个三个月，既不接受或同时接受SP治疗(所有组都接受SP)的推定AZM(2g)治疗的疗效；以及(2)在HIV(+)、TB感染的PW中进行单独的双臂试验，以比较9个月异烟肼300 mg/d的标准方案与3个月异烟肼(300 mg/d)加利福平(600 mg/d)的短程方案治疗潜伏的结核分枝杆菌感染的安全性(和依从性)。 该项目是在资源匮乏的非洲开发一种综合、实用的方法来管理高度流行的疟疾、性传播感染和结核病的首批尝试之一。它将建立在美国和金沙萨研究人员之间富有成效的合作历史上，特别是SIDA项目，在那里，PW的大型纵向队列研究已经成功。它还将建立和加强金沙萨公共卫生学院新兴的多学科研究和培训计划。