Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Investigational Reflex Test 1
  Investigational Reflex Test 1
• Диагностический тест Investigational Reflex Test 2
  Investigational Reflex Test 2
• Диагностический тест Investigational Reflex Test 3
  Investigational Reflex Test 3

Первичные конечные точки

• Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs [Срок оценки: One day]
• Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs [Срок оценки: One day]

Вторичные конечные точки (9)

• Number of invalid results for Investigational Reflex Test 1 in urine [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 1 in vaginal swabs [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 2 in urine [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 2 in vaginal swabs [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 3 in urine [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 3 in vaginal swabs [Срок оценки: One day]
• Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs [Срок оценки: One day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 8 центров

• San Francisco Public Health Laboratory — San Francisco
• Indiana University School of Medicine — Indianapolis
• Mississippi State Department of Public Health — Jackson
• Corewell Health — Royal Oak
• LabCorp — Durham
• ARUP Laboratories — Salt Lake City
• University of Virginia School of Medicine — Charlottesville
• Molecular Testing Labs — Vancouver

Идентификаторы

NCT: NCT06815536 · Pro00113379 · UM1AI104681

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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