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: 6804022
• 负责人: Robert W. Ryder
• 金额: $ 64.66万
• 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/6804022
• 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（由申请人提供）：疟疾、性传播感染（STIs）和结核病（TB）在撒哈拉以南非洲的孕妇（PW）中很常见，是导致不良分娩结果和孕产妇发病率和死亡率的重要可预防原因。非洲的许多产妇寻求产前护理，但没有得到适当的护理，尽管抗生素或抗疟药的推定治疗和结核病的预防性治疗可能有效。因此，产前检查是在资源贫乏的环境中“错失了改善母婴健康的机会”。