RESOLUTIONS OF SEXUALLY ACQUIRED ENDOMETRITIS

性获得性子宫内膜炎的解决方案

• 批准号: 3791803
• 负责人: PETER A RICE
• 金额: --
• 依托单位: BOSTON CITY HOSPITAL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3791803
• 关键词: Chlamydia trachomatis; Neisseria gonorrhoeae; beta lactam antibiotic; bioassay; biopsy; cervix disorder; chlamydial disease; clinical trials; communicable disease transmission; disease /disorder proneness /risk; drug administration rate /duration; endometrium; female; gonorrhea; histopathology; human subject; human therapy evaluation; inflammation; microorganism culture; microorganism disease chemotherapy; microorganism interaction; pelvic inflammatory disease; reproductive system disorder chemotherapy; sex partner; sexually transmitted diseases; urethritis

Women who are sexual contacts of men with urethritis will be identified to determine the prevalence of silent endometritis, its "natural history", and its response to medical therapy. ("Natural history" is defined here as the course of silent endometritis treated as uncomplicated cervicitis.) We will enroll a subgroup of the core patient group, as epidemiologically defined in Core 2 - female contacts of male patients with urethritis of known cause. The natural history component will compare these women documented to have cervical infection with N. gonorrhoeae and/or C. trachomatis (study group) to a demographically similar group who are uninfected (control group). We will determine the prevalence of endometritis diagnosed histopathologically in each group and the rate of resolution of endometritis after identical treatment. After endometrial biopsy, both groups of patients will receive regimens of ceftriaxone and seven days doxycycline. Using two follow-up biopsies - one at 4 weeks and one at 8 weeks, we will determine whether the rate of resolution of endometrial inflammation and secondary pathologic changes are different in the two groups. The treatment trial will compare the same group of patients with documented cervical infection (study group) receiving standard treatment for cervicitis with ceftriaxone and doxycycline, to a similarly infected group who will receive ceftriaxone and 14 days (instead of 7) of doxycycline (extended therapy group). Assignment to the two groups will be randomized and double blinded. Extent of improvement and frequency of cure defined by rigorous histopathologic criteria will be compared in each group. Patients' response to therapy will be assessed by repeat endometrial biopsies and follow-up cultures at 4 and 8 weeks after entry. The role of non-chlamydial, non-gonococcal bacterial infection in the persistence of endometrial infection and inflammation and the role that primary pathogens such as N. gonorrhoeae and C. trachomatis play in persistence of endometritis with other organisms, will also be determined for the three groups.

与患有尿道炎的男性发生性接触的女性将被确定为 确定无症状子宫内膜炎的患病率及其“自然史”，以及 它对药物治​​疗的反应。 （“自然历史”在这里被定义为 无症状子宫内膜炎的病程被视为单纯性宫颈炎。）我们 将招募核心患者组的一个亚组，从流行病学角度来看 核心 2 中的定义 - 男性尿道炎患者的女性接触者 已知原因。 自然历史部分将比较这些女性 据记录患有淋病奈瑟菌和/或衣原体宫颈感染。 沙眼衣原体（研究组）与人口统计相似的群体 未感染者（对照组）。 我们将确定患病率 各组子宫内膜炎组织病理学诊断率及发生率 相同治疗后子宫内膜炎消退。 子宫内膜后 活检后，两组患者均接受头孢曲松和 7天多西环素。 使用两次后续活检 - 一次在 4 周时进行， 第 8 周时，我们将确定解决率是否 子宫内膜炎症和继发性病理改变不同 两组。 治疗试验将比较同一组患者的记录 宫颈感染（研究组）接受标准治疗 使用头孢曲松和多西环素治疗类似感染组的宫颈炎 谁将接受头孢曲松和 14 天（而不是 7 天）强力霉素 （延长治疗组）。 两组的分配将是随机的 和双盲。 改善程度和治愈频率定义为 将在每组中比较严格的组织病理学标准。 患者对治疗的反应将通过重复子宫内膜检查来评估 进入后4周和8周进行活检和后续培养。 非衣原体、非淋菌感染在疾病中的作用 子宫内膜感染和炎症的持续存在及其作用 主要病原体如淋病奈瑟菌和沙眼衣原体在 子宫内膜炎与其他生物体的持续存在也将被确定 对于三组。