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Identifying Optimal Antibiotic Regimens to Treat Urinary Tract Infections During Pregnancy

确定治疗妊娠期尿路感染的最佳抗生素方案

基本信息

批准号：
10522361
负责人：
Anne Mobley Butler
金额：
$ 71.89万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-01 至 2027-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10522361
关键词：
Address Adverse drug event Adverse event Affect Ambulatory Care American College of Obstetricians and Gynecologists Antibiotic Resistance Antibiotic Therapy Antibiotics Antimicrobial Resistance Antimicrobial susceptibility Bacteriuria Benefits and Risks Calendar Cardiac Clinical Clinical Trials Clostridium difficile Congenital Abnormality Data Databases Diarrhea Effectiveness Electronic Health Record Evaluation Exanthema First Pregnancy Trimester Geographic Locations Gestational Age Guidelines Healthcare Systems Hypersensitivity Infant Knowledge Low Birth Weight Infant Microbiology Modernization Neonatal Nitrofurantoin Obesity Observational Study Outcome Outpatients Patients Pattern Pharmaceutical Preparations Population Heterogeneity Predisposition Pregnancy Pregnant Women Premature Birth Premature Labor Pyelonephritis Randomized Clinical Trials Recording of previous events Regimen Research Design Risk Risk Estimate Safety Sample Size Second Pregnancy Trimester Selection for Treatments Sepsis Smoking Status Sulfonamides Teratogens Third Pregnancy Trimester Time Treatment Failure Treatment Protocols Uncertainty Urinary tract infection Uropathogen Variant Woman administrative database antibiotic resistant infections antimicrobial antimicrobial drug beta-Lactams clinical decision-making comparative safety cost efficient early pregnancy effectiveness analysis epidemiology study follow-up improved insight microbiome optimal treatments oral cleft pathogen perinatal complications perinatal outcomes pregnant prevent prospective randomized trial screening guidelines standard care standard of care stillbirth treatment duration treatment risk urinary

项目摘要

PROJECT SUMMARY / ABSTRACT UTIs occur in 8% of pregnant women, affecting ~500,000 women annually in the U.S. Serious maternal and infant consequences include pyelonephritis, sepsis, preterm labor, and low birth weight. Guidelines recommend screening and empirical treatment of UTIs (including asymptomatic bacteriuria) in early pregnancy. This approach has become standard of care, yet there is a lack of rigorous evidence to inform antibiotic selection or duration in pregnant women. Most evidence about the benefits and harms of antibiotic regimens has been generated by randomized clinical trials that excluded pregnant women, and which are further limited by small sample size, short follow-up, and heterogeneous treatments. Despite clear guidelines for non-pregnant women, treatment standards for pregnant women are vague. The American College of Obstetricians and Gynecologists (ACOG) recommends nitrofurantoins and sulfonamides as first-line during the second and third trimesters, but provides no guidance for first trimester management. Uncertainty remains about the teratogenicity of nitrofurantoins and sulfonamides due to limitations of previous observational studies. In addition, ACOG does not define appropriate antibiotic duration, instead recommending the “shortest effective duration.” Overall, the lack of guidance about antibiotic selection and treatment duration leads to substantial practice variation and the potential for harm. For example, clinicians commonly prescribe broad- spectrum agents despite antimicrobial stewardship initiatives that recommend narrow-spectrum agents. Providing optimal antibiotic agents and durations could prevent avoidable adverse events, microbiome disruption, and antibiotic-resistant infections. A comprehensive evaluation using real-world data is needed to quantify the benefits and risks of commonly used antibiotic regimens to treat pregnant women with UTI. We will conduct a non-experimental study to examine the utilization, effectiveness, and safety of several commonly used antibiotic regimens in a real-world setting of diverse pregnant women in the U.S. We will apply modern epidemiological study design and analytic approaches to study almost two million pregnant antibiotic recipients and a subset of their infants, from two national databases as well as EHR data from three regional healthcare systems. Our utilization analysis will use microbiology results to characterize variability in antibiotic prescribing within the context of local uropathogen susceptibility patterns. Our antibiotic effectiveness analyses will provide insight into whether the risks of antibiotic treatment failure outcomes vary by antibiotic regimen. Our safety analyses will compare the risk of birth defects and other perinatal complications by antibiotic regimen. Exploratory analyses will examine additional adverse drug events (e.g., Clostridioides difficile diarrhea). This large study will generate evidence to address critical gaps in knowledge about optimal treatment of UTIs in pregnant women. Our results will inform clinical decision-making and reduce suboptimal antibiotic prescribing, which will ultimately prevent adverse events, improve perinatal outcomes, and minimize antibiotic resistance.

项目摘要/摘要