Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) Trial

剖腹产最佳抗生素预防 (C/SOAP) 试验

• 批准号: 8305724
• 负责人: ALAN THEVENET N. TITA
• 金额: $ 59.3万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-20 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8305724
• 关键词: Abscess; Accounting; Address; Adverse effects; Alabama; Allergic; Amniotic Fluid; Antibiotic Prophylaxis; Antibiotics; Azithromycin; Bacteremia; Bacteria; Biological; Bronchopulmonary Dysplasia; Cefazolin; Centers for Disease Control and Prevention (U.S.); Cephalosporins; Cesarean section; Cessation of life; Clindamycin; Clinical Trials Design; Conduct Clinical Trials; Data; Discipline of obstetrics; Dose; Effectiveness; Emergency Situation; Endometritis; Enrollment; Exposure to; Face; Frequencies; Future; Genital system; Healthcare; High Risk Woman; Human; Hypersensitivity; Incidence; Individual; Infection; Intravenous; Length of Stay; Medical; Membrane; Microbe; Morbidity - disease rate; Mothers; Multi-Institutional Clinical Trial; Mycoplasma; Neonatal; Newborn Infant; North Carolina; Operative Surgical Procedures; Organism; Outcome; Perinatal; Perinatal Exposure; Pharmaceutical Preparations; Placebos; Pneumonia; Postpartum Period; Pregnancy; Premature Infant; Prophylactic treatment; Publishing; Pyloric Stenosis; Randomized; Randomized Clinical Trials; Reaction; Recommendation; Regimen; Relative (related person); Research Personnel; Resistance; Resources; Risk; Risk Factors; Rupture; Safety; Schedule; Sepsis; Sepsis Syndrome; Site; Specimen; Surgical incisions; Texas; Thrombosis; Umbilical Cord Blood; Umbilical cord structure; Universities; Ureaplasma; Vaginal delivery procedure; Woman; Wound Infection; base; comparative effectiveness; cost effective; experience; fetal; innovation; pathogen; preference; prenatal; prenatal exposure; prevent; public health priorities; public health relevance; randomized trial; safety study; septic; wound

DESCRIPTION (provided by investigator): The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin prior to surgical incision to prevent post-cesarean infection. In contrast to cephalosporin, azithromycin is effective against other common pathogens, especially ureaplasma, a strong risk factor for post-cesarean endometritis when present in the chorioamnion, and the most common isolate from wound infections. Our preliminary studies suggest that extended-spectrum prophylaxis may effectively lower the risk of post-cesarean infection compared to standard cephalosporin alone. We will enroll women at high risk for post-cesarean infection despite standard prophylaxis - those undergoing a non-elective cesarean during labor or after membrane rupture. These women face a high likelihood of ascending colonization and infection with ureaplasmas from the lower genital tract. During the 4-year project period, 3 collaborating perinatal centers, recognized nationally for their expertise in the conduct of multi-center clinical trials, will randomize 2000 women undergoing non-elective (unscheduled) cesarean to either 500mg of intravenous azithromycin or identical placebo initiated prior to surgery; concurrently, both groups will also receive standard single-dose cefazolin prophylaxis (or clindamycin if allergic to cephalosporin). Women will be followed for at least 30 days according to CDC recommendations for ascertaining surgical site infections. Neonatal outcomes will also be recorded. The following specific aims will be addressed: Specific aim 1 (Effectiveness): To determine if pre-incision extended-spectrum prophylaxis reduces the risk of post-cesarean infection (endometritis, wound or other infections) compared to standard cephalosporin alone among women undergoing unscheduled cesarean delivery. {Specific aim 2 (Safety): To evaluate the safety of azithromycin-based pre-incision extended spectrum prophylaxis relative to standard cephalosporin prophylaxis in terms of the frequency of adverse composite and individual neonatal and maternal outcomes including suspected or proven neonatal infection, drug reactions or side effects including neonatal pyloric stenosis, and infection with resistant organisms.} {Specific aim 3: To collect and store biological specimens (umbilical cord blood and amniotic fluid) for future studies, primarily to assess the association between prenatal exposure to ureaplasmas and adverse neonatal outcomes (systemic inflammatory response syndrome, sepsis, pneumonia and bronchopulmonary dysplasia and death) and the potential for prenatal azithromycin use to prevent these outcomes.} PUBLIC HEALTH RELEVANCE: We propose a large multi-center randomized trial to evaluate the benefits and safety of an innovative antibiotic prophylaxis strategy at cesarean delivery to reduce the incidence of infection, one of the top 5 causes of pregnancy-related death and illness in the US. The regimen adds a second antibiotic to the standard cephalosporin to extend the spectrum of coverage to other common bacteria especially ureaplasmas. Preliminary data from a single center suggest that this extended-spectrum antibiotic prophylaxis regimen may significantly reduce post-cesarean infections among women undergoing cesarean delivery. The trial will be conducted at 3 Ob/Gyn departments experienced in the conduct of clinical trials: University of Alabama at Birmingham, University of North Carolina, Chapel Hill and University of Texas Medical Branch in Galveston.

DESCRIPTION (provided by investigator): The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent在手术切口前的头孢菌素，以防止后疗法感染。与头孢菌素相比，阿奇霉素对其他常见病原体有效，尤其是尿素超倍时间，这是在绒毛膜膜中存在的强大疗法子宫内膜炎的强大危险因素，以及来自伤口感染的最常见的分离株。我们的初步研究表明，与单独的头孢菌素相比，延长的预防性预防可能有效地降低了疗养后感染的风险。尽管有标准的预防症，我们仍将招募妇女受到高风险的审查后感染 - 那些在劳动期间或膜破裂后经历了非选择性剖宫产的妇女。这些妇女面临着从下生殖道的尿素上升高和感染尿素的可能性很大的可能性。在4年的项目期间，3个合作的围产期中心因其在多中心临床试验中的专业知识而在全国范围内认可，将将2000名经历非安全性（未切除）樱桃的妇女与500mg静脉静脉静脉植物或同一地认同的安慰剂开始。同时，这两组还将接受标准的单剂量头孢唑素预防（或克林霉素对头孢菌素过敏）。根据疾病预防控制中心（CDC）的建议，将至少遵循30天的妇女，以确定手术部位感染。新生儿结果也将被记录。将解决以下具体目标：具体目标1（有效性）：确定与在未进行的胸甲分娩的女性中，与单独的头孢菌素相比，与单独进行的标准头孢菌素相比，与单独的头孢菌素相比，在赛后感染后感染（子宫内膜炎，伤口或其他感染）是否降低了赛后感染的风险。 {具体目的2（安全）：以相对于标准的头孢菌素预防的频谱预防的安全性，以不良复合材料和个体新生儿和孕产妇结局的频率（包括可疑的或经过证实的新生儿感染），包括新生儿反应，药物反应，包括新生症和副作用。 {具体目的3：用于未来研究的收集和存储生物学标本（脐带血和羊水液），主要是评估产前暴露于尿素超临床和不良新生儿结局之间的关联结果。} 公共卫生相关性：我们提出了一项大型多中心随机试验，以评估剖宫产上创新的抗生素预防策略的益处和安全性，以减少感染的发生率，这是美国与妊娠相关死亡和疾病的前5个原因之一。该方案为标准的头孢菌素增加了第二种抗生素，以将覆盖范围扩展到其他常见细菌，尤其是尿素倍率。来自单个中心的初步数据表明，这种扩展的抗生素预防疗法可能会大大减少剖宫产妇女的疗法后感染。该试验将在临床试验的3个OB/GYN系进行：阿拉巴马大学伯明翰大学，北卡罗来纳大学，教堂山和德克萨斯大学医学分支机构的加尔维斯顿分校。