Neisseria Gonorrheae Infection
Conditions
Keywords
mutant allele gyrA 91F, wildtype allele gyrA 91S, ciprofloxacin-resistant Neisseria gonorrhoeae
Brief summary
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_TESTInvestigational Reflex Test 1
Investigational Reflex Test 1
DIAGNOSTIC_TESTInvestigational Reflex Test 2
Investigational Reflex Test 2
DIAGNOSTIC_TESTInvestigational Reflex Test 3
Investigational Reflex Test 3
Sponsors
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
SpeeDx Pty Ltd
Abbott
Seegene USA Inc
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael J. Satlin, MD, MS
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORJeffrey D. Klausner, MD, MPH
University of Southern California - Los Angeles
STUDY_DIRECTORVance G. Fowler, MD, MHS
Duke University
Outcome results
None listed