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

比较头孢克肟与青霉素 G 治疗早期梅毒疗效的临床试验

基本信息

批准号：
10652990
负责人：
Jeffrey David Klausner
金额：
$ 61万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-13 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10652990
关键词：
Address Adherence Aftercare Allergic Antibiotic Therapy Antibiotics Benzathine Penicillin Biological Availability CD4 Positive T Lymphocytes California Case Series Cefixime Ceftriaxone Cell Count Cephalosporins Characteristics Clinical Clinical Markers Clinical Trials Data Data Collection Development Dose Doxycycline Early treatment Enrollment Generations HIV HIV Infections Human Incidence Individual Infection Injectable Injections International Intramuscular Macrolides Monitor Oral Oral Administration Oral cavity Outcome Participant Patients Penicillin Allergy Penicillin G Penicillins Persons Peru Phase Pilot Projects Prediction of Response to Therapy Pregnancy Randomized Recommendation Recording of previous events Regimen Research Review Literature Serology Serum Site Symptoms Syphilis Tetracyclines Time Toxic effect Training Treatment Failure United States Food and Drug Administration Viral Load result alternative treatment arm beta-Lactams clinical research site compare effectiveness cost design effective therapy effectiveness evaluation efficacy evaluation experience experimental arm follow-up instrument men who have sex with men novel novel strategies open label participant enrollment pharmacologic recruit response study population treatment arm treatment duration

项目摘要

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.

项目摘要拟议的项目旨在评估头孢克雷米的有效性（每天两次，每天两次，持续10天）与苯甲胺青霉素G（240万个单位，肌肉内）相比感染。在美国和国际上，梅毒率一直在上升。发生率更高男性 - 与艾滋病毒感染的患者有关的人，更重要的是。目前，使用青霉素在患有和没有HIV感染的患者中治疗梅毒。强力霉素，四环素和头孢曲松是对青霉素过敏的非妊娠患者的替代治疗。现有的治疗替代品基于临床经验，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选择。在这项建议中，我们将基于我们成功的试点研究，以进行随机，多站点，开放标签，非 - 与头孢菌素的有效性（每天两次，每天两次，持续10天）评估自卑临床试验患有和没有HIV感染的患者的苯甲胺青霉素G（240万个单位，肌肉内）。我们将注册 400名来自美国和秘鲁9个临床部位的梅毒早期感染的参与者。我们将遵循参与者每3个月一次监测每3个月的临床进度和血清学反应（RPR滴度）。我们的假设是头孢菌素在治疗梅毒时将不属于青霉素，显示为4倍的降低治疗给药后从入学到6个月的RPR滴度。这些是我们的两个具体目标提议。 AIM 1：与相比苯甲胺青霉素G. AIM 2：确定参与者治疗失败的预测因素。 5年项目有4个阶段。第一阶段将持续9个月，并将涉及研究的发展仪器，招聘人员培训，入学率和数据收集。第二阶段将持续36个月，将涉及患者的招募和入学。第三阶段将持续45个月，但将同时开始作为第二阶段，将包括患者的随访期。第四阶段将持续6个月，在那段时间里，数据将进行分析和传播。

项目成果

期刊论文数量（4）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Consistency of Condom Use During Receptive Anal Intercourse Among Women and Men Who Have Sex With Men: Findings From the Safe in the City Behavioral Study.

DOI：
10.1097/olq.0000000000000306
发表时间：
2015-07
期刊：
Sexually transmitted diseases
影响因子：
3.1
作者：
DʼAnna LH;Warner L;Margolis AD;Korosteleva OA;OʼDonnell L;Rietmeijer CA;Klausner JD;Malotte CK;Safe in the City Study Group
通讯作者：
Safe in the City Study Group

SARS-CoV-2 Case-Definitions Must Include Clinical Criteria: Reply to Kojima et al.

SARS-CoV-2 病例定义必须包括临床标准：回复 Kojima 等人。

DOI：
10.1093/cid/ciad413
发表时间：
2023
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
0
作者：
Allan-Blitz,Lao-Tzu;Klausner,JeffreyD
通讯作者：
Klausner,JeffreyD

Additional Public Health Benefits of HIV Partner Services and More Opportunities for Improvement.

HIV 合作伙伴服务的额外公共卫生益处和更多改进机会。