Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,627
- 试验地点
- 16
- 主要终点
- Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
研究概览
简要总结
The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer:
Can the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result?
Specimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.
详细描述
This is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for N. gonorrhoeae using an FDA-cleared molecular assay. The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance in N. gonorrhoeae, as compared to a reference standard of Sanger sequencing of the gyrA codon 91. Specimens will be tested via a reference standard of Sanger sequencing and one investigational reflex test. The target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be N. gonorrhoeae-positive on an FDA-cleared molecular assay
- •Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing
- •Undergo proper handling and storage conditions
排除标准
- •The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site
- •The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source
研究组 & 干预措施
Vaginal Swab
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.
干预措施: Investigational Reflex Test 1 (Diagnostic Test)
Urine
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.
干预措施: Investigational Reflex Test 1 (Diagnostic Test)
Urine
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.
干预措施: Investigational Reflex Test 2 (Diagnostic Test)
Urine
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.
干预措施: Investigational Reflex Test 3 (Diagnostic Test)
Vaginal Swab
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.
干预措施: Investigational Reflex Test 3 (Diagnostic Test)
Pharyngeal Swabs
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.
干预措施: Investigational Reflex Test 1 (Diagnostic Test)
Pharyngeal Swabs
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.
干预措施: Investigational Reflex Test 3 (Diagnostic Test)
Vaginal Swab
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.
干预措施: Investigational Reflex Test 2 (Diagnostic Test)
Pharyngeal Swabs
Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.
干预措施: Investigational Reflex Test 2 (Diagnostic Test)
结局指标
主要结局
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
时间窗: One day
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs
时间窗: One day
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs
时间窗: One day
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine
时间窗: One day
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs
时间窗: One day
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs
时间窗: One day
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine
时间窗: One day
Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs
时间窗: One day
Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs
时间窗: One day
Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
次要结局
- Number of invalid results for Investigational Reflex Test 1 in urine(One day)
- Number of invalid results for Investigational Reflex Test 1 in vaginal swabs(One day)
- Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs(One day)
- Number of invalid results for Investigational Reflex Test 2 in urine(One day)
- Number of invalid results for Investigational Reflex Test 2 in vaginal swabs(One day)
- Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs(One day)
- Number of invalid results for Investigational Reflex Test 3 in urine(One day)
- Number of invalid results for Investigational Reflex Test 3 in vaginal swabs(One day)
- Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs(One day)