Comparative Safety of Antibiotics for Common Bacterial Infections During Pregnancy

妊娠期常见细菌感染抗生素的比较安全性

• 批准号: 10391036
• 负责人: Yanmin Zhu
• 金额: $ 64.57万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-02 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10391036
• 关键词: Address; Advisory Committees; Age; Antibiotic Therapy; Antibiotics; Area; Bacterial Infections; Benefits and Risks; Cellulitis; Centers for Disease Control and Prevention (U.S.); Cephalosporins; Chlamydia; Clindamycin; Clinical; Conflict (Psychology); Confounding Factors (Epidemiology); Congenital Abnormality; Data; Data Sources; Databases; Ensure; Evaluation; Exposure to; Fetus; Fluoroquinolones; Fosfomycin; Goals; Gonorrhea; Human; Infection; Lower Respiratory Tract Infection; Macrolides; Medicaid; Neonatal; Neonatal Jaundice; Neonatal Mortality; Nitrofurantoin; Observational Study; Outcome; Penicillins; Pharmaceutical Preparations; Pregnancy; Pregnancy Outcome; Pregnant Women; Preventive service; Research; Residual state; Respiratory Tract Infections; Risk; Safety; Sexually Transmitted Diseases; Signal Transduction; Specific qualifier value; Spontaneous abortion; Teratogens; Tetracyclines; Toxic effect; Trimethoprim-Sulfamethoxazole; United States Food and Drug Administration; Urinary tract infection; Vulnerable Populations; Woman; adverse maternal outcomes; adverse outcome; animal data; antimicrobial; cohort; comparative safety; comparison group; detection method; disability; early pregnancy; fetal; malformation; medication safety; member; neonatal morbidity; novel; optimal treatments; pregnant; prenatal exposure; prevent; reproductive; skin abscess; treatment strategy; vaccine safety

The most common bacterial infections during pregnancy include urinary tract infections, cellulitis and skin abscesses, upper and lower respiratory tract infections, and sexually transmitted diseases. Management of bacterial infections in pregnant women requires early antimicrobial treatment to prevent adverse maternal and pregnancy outcomes. As such, antibiotics are among the most commonly used medications in pregnancy – approximately six out of ten publicly insured and four out of ten commercially insured pregnant women fill at least one antibiotic prescription during pregnancy. To select the optimal antibiotic from the range of available options for specific infections, it is therefore crucial to understand the comparative safety of in utero exposure to specific antibiotics. Unfortunately, rigorous and comprehensive safety data to inform the risk-benefit trade-off are sparse and evidence is conflicting. The primary concern among potential risks associated with antibiotic use in pregnancy are congenital malformations, which are a leading cause of neonatal morbidity and mortality, and frequently cause lifelong disability. Additionally, some studies have pointed to an increased risk of spontaneous abortions and neonatal jaundice associated with some commonly used classes of antibiotics. Given that 45% of pregnancies in the US are unintended, understanding the comparative safety of antibiotics in early pregnancy may also inform the selection of antibiotics in women of reproductive age. The objective of the proposed studies is therefore to evaluate the comparative safety of antibiotics commonly used for the treatment of bacterial infections during pregnancy. To accomplish this, we will employ large pregnancy cohorts of publicly and privately insured pregnant women (N ≈ 4.5 million). For each of the most common bacterial infections, we will assess the comparative safety of available commonly used antibiotic treatment options and utilize the rich information in our data sources to control for potential confounding variables. The large study size will enable quantification of effects for the pre-specified outcomes (i.e., malformations overall, specific malformation types, spontaneous abortion, and neonatal jaundice) with great precision. In addition, to ensure a comprehensive evaluation of the comparative safety, we will utilize a novel signal detection method developed by members of our team, TreeScan, for simultaneous evaluation of a broad range of potential maternal, fetal and neonatal adverse outcomes. By harnessing the power of existing real-world data, this study will inform strategies for tailoring antibiotic treatment to optimize pregnancy outcomes in this vulnerable population. As such, the proposed study aligns well with the main goal of PAR-20-300. By defining the safest treatment options for women of reproductive age with bacterial infections, the findings of this study will have direct and immediate clinical impact.

怀孕期间最常见的细菌感染包括尿路感染、蜂窝织炎和皮肤感染 脓肿、上呼吸道和下呼吸道感染以及性传播疾病的治疗。 孕妇细菌感染需要及早进行抗菌药物治疗，以预防母婴不良反应 因此，抗生素是妊娠期最常用的药物之一。 大约十分之六的公共保险孕妇和十分之四的商业保险孕妇参加了 怀孕期间至少开出一种抗生素处方。 因此，要从针对特定感染的可用选项中选择最佳抗生素，至关重要 不幸的是，要了解子宫内暴露于特定抗生素的相对安全性，需要严格和严格的。 用于告知风险收益权衡的全面安全数据很少，而且证据也相互矛盾。 与妊娠期使用抗生素相关的潜在风险中最令人担忧的是先天性 畸形是新生儿发病和死亡的主要原因，并且经常导致终生 此外，一些研究指出自然流产和新生儿的风险增加。 鉴于美国 45% 的妊娠发生黄疸与某些常用抗生素相关。 是无意的，了解妊娠早期抗生素的相对安全性也可能为人们提供信息 育龄妇女抗生素的选择。 因此，拟议研究的目的是评估常用抗生素的相对安全性 用于治疗怀孕期间的细菌感染 为了实现这一目标，我们将雇用大量人员。 公共和私人保险孕妇的妊娠队列（N 约 450 万）。 常见细菌感染，我们将评估现有常用抗生素的相对安全性 治疗方案并利用我们数据源中的丰富信息来控制潜在的混淆 大型研究规模将能够量化预先指定的结果（即， 总体畸形、特定畸形类型、自然流产和新生儿黄疸） 此外，为了确保比较安全性的综合评估，我们将利用一种新颖的方法。 由我们团队成员开发的信号检测方法 TreeScan，用于同时评估广泛的信号 一系列潜在的孕产妇、胎儿和新生儿不良后果。 通过利用现有现实世界数据的力量，这项研究将为定制抗生素的策略提供信息 因此，拟议的研究与此一致。 通过为育龄妇女确定最安全的治疗方案，很好地实现了 PAR-20-300 的主要目标。 对于细菌感染，这项研究的结果将产生直接和直接的临床影响。