Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

项目摘要 拟议的项目旨在评估头孢克新(400毫克，一天两次，共10天)的疗效。 与苄星青霉素G(240万单位，肌肉注射)相比，在感染和不感染艾滋病毒的患者中 感染。在美国和国际上，梅毒发病率一直在上升。发病率较高的是 与男性发生性行为的男性，更重要的是感染艾滋病毒的个人。目前，使用的是青霉素 治疗感染和不感染艾滋病毒患者的梅毒。强力霉素、四环素和头孢曲松分别为 对青霉素过敏的非怀孕患者的替代治疗。现有的治疗替代方案 都是基于临床经验、有限数量的小型临床试验和病例系列，但每个姿势 临床挑战。需要新的、安全有效的抗生素治疗方案。 在这项提案中，我们将在我们成功的试点研究的基础上，进行一项随机的、多站点的、开放标签的、非 评价头孢克新(400 mg，一天两次，共10天)的疗效的劣势临床试验 苄星青霉素G(240万单位，肌肉注射)在有和没有艾滋病毒感染的患者中。我们将招收 来自美国和秘鲁9个临床地点的400名早期梅毒感染患者。我们将遵循 参与者每3个月监测临床进展和血清学反应(RPR效价)，为期9个月。我们的 假设头孢克新在治疗梅毒方面不比青霉素差，表现为4倍于青霉素 RPR滴度从入选到治疗后6个月。这是我们的两个具体目标 求婚。目的1：评价头孢克新治疗早期梅毒的疗效。 目的：确定受试者治疗失败的预测因素。 五年计划分4个阶段。第一阶段为期9个月，将涉及研究的发展 工具、招聘、登记和数据收集方面的工作人员培训。第二阶段将持续36个月，将 包括招募和招收病人。第三阶段，将持续45个月，但同时开始 作为第二阶段，并将包括患者随访期。第四阶段将持续6个月，在此期间，数据 将被分析和传播。

PROJECT ABSTRACT The proposed project is designed to evaluate the effectiveness of cefixime (400mg, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. Syphilis rates have been increasing both in the US and internationally. Incidence is higher among men-who-have-sex-with-men and more importantly in individuals with HIV infection. Currently, penicillin is used to treat syphilis in patients with and without HIV infection. Doxycycline, tetracycline and ceftriaxone are alternative treatments for non-pregnant patients who are allergic to penicillin. Existing treatment alternatives are based on clinical experience, a limited number of small clinical trials, and case series, but each poses clinical challenges. New, safe and efficacious antibiotic treatment options are needed. In this proposal, we will build upon our successful pilot study to conduct a randomized, multisite, open-label, non- inferiority clinical trial to evaluate the effectiveness of cefixime (400mg, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. We will enroll 400 participants with early syphilis infection from 9 clinical sites in the U.S. and Peru. We will follow the participants to monitor clinical progress and serological response (RPR titer) every 3 months for 9 months. Our hypothesis is that cefixime will be non-inferior to penicillin in treating syphilis, shown as a 4-fold decrease in RPR titer from enrollment to 6-months after treatment administration. These are the two specific aims of our proposal. AIM 1: Evaluate the effectiveness of cefixime in the treatment of early syphilis when compared to benzathine penicillin G. AIM 2: Determine the predictors of treatment failure among participants. The 5 year project has 4 phases. Phase I will last 9 months and will involve the development of study instruments, staff training on recruitment, enrollment, and data collection. Phase II will last 36 months and will involve recruitment and enrollment of patients. Phase III which will last 45 months, but will start simultaneously as stage II, and will include the patient follow-up period. Phase IV will last 6 months and in that time, the data will be analyzed and disseminated.