Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational Reflex Test 1, Investigational Reflex Test 2, Investigational Reflex Test 3.
- Who it may be relevant to
- Registry conditions: Neisseria Gonorrheae Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Investigational Reflex Test 1
Investigational Reflex Test 1 - Diagnostic test Investigational Reflex Test 2
Investigational Reflex Test 2 - Diagnostic test Investigational Reflex Test 3
Investigational Reflex Test 3
Primary outcome measures
- Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs [Time frame: One day]
- Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs [Time frame: One day]
Secondary outcome measures (9)
- Number of invalid results for Investigational Reflex Test 1 in urine [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 1 in vaginal swabs [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 2 in urine [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 2 in vaginal swabs [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 3 in urine [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 3 in vaginal swabs [Time frame: One day]
- Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs [Time frame: One day]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 8 centers
- 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
Identifiers
NCT: NCT06815536 · Pro00113379 · UM1AI104681