Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Identification of Novel Organsims from PRO10010159
研究概览
简要总结
The goal of this project is to identify the microorganisms present in the endometrial samples obtained from women with or without evidence of endometritis using a combination of culture methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies is to identify the etiology of endometritis. The investigators will define the role of fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic treatment regimens used for the treatment of PID have activity against the novel organisms linked with pelvic infections.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •This is a laboratory research study involving the use of biologic specimens only.
- •Specimens (endometrial biopsy samples) collected from subjects who meet the inclusion criteria for PRO10010159 and PRO10010112 will be utilized for this study.
排除标准
- •Specimens (endometrial biopsy samples) that are collected from subjects enrolled in PRO10010159 and PRO10010112 that are insufficient will not be included in this study.
结局指标
主要结局
Identification of Novel Organsims from PRO10010159
时间窗: 12 months after participant enrollment in PRO10010159
This study will use optimized culture methods which can support the growth of fastidious organisms to describe the microorganisms in endometrial tissue samples obtained from the 200 women enrolled in the cervicitis cohort (PRO10010159, T Cell Response).
Identification of Novel Organisms from PRO10010112
时间窗: 30 days after participant enrollment in PRO10010112
This study will use optimized culture methods which can support the growth of fastidious organisms to describe the microorganisms in endometrial tissue samples obtained from 250 women enrolled in the acute PID study before and after treatment (PRO10010112, Acute PID treatment).
次要结局
未报告次要终点
研究者
Sharon Hillier
Professor
University of Pittsburgh