Investigational Reflex Test 1
Diagnostic TestInvestigational Reflex Test 1
Recruiting
NCT Number: NCT06815536
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
San Francisco Public Health Laboratory, San Francisco, California, United States
Loading trial locations.
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Investigational Reflex Test 2
Diagnostic TestInvestigational Reflex Test 2
Investigational Reflex Test 3
Diagnostic TestInvestigational Reflex Test 3
Primary outcomes
-
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Michael J. Satlin, MD, MS
CONTACT
Nyssa Schwager, MSN, RN
CONTACT
Sponsors and collaborators
Lead sponsor
Duke University
Other
Collaborators
- Abbott
- National Institute of Allergy and Infectious Diseases (NIAID)
- Seegene USA Inc
- SpeeDx Pty Ltd
Registry information
Acronym: MASTERMINDRING
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 7, 2025
- Registry last updated
- Mar 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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