Neisseria Gonorrheae InfectionMASTERMINDRINGNCT06815536

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

An observational study of Neisseria Gonorrheae Infection, run by Duke University at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Neisseria Gonorrheae Infection
What is being tested?: Investigational Reflex Test 1, Investigational Reflex Test 2 and Investigational Reflex Test 3
How many people: 2,627 participants
Where: 8 sitesUnited States
Study dates: 16 Apr 2025to 31 Jul 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Clinical specimens from male and females that test positive for Neisseria gonorrhoeae

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Virginia School of Medicine
Charlottesville, Virginia, 22908
LabCorp
Durham, North Carolina, 27703
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Mississippi State Department of Public Health
Jackson, Mississippi, 39216
Corewell Health
Royal Oak, Missouri, 48073
ARUP Laboratories
Salt Lake City, Utah, 84108
San Francisco Public Health Laboratory
San Francisco, California, 94102
Molecular Testing Labs
Vancouver, Washington, 98684

Other trials in United States

About this study

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.

Read the 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.

Conditions: Neisseria Gonorrheae Infection
Being tested: Investigational Reflex Test 1, Investigational Reflex Test 2, Investigational Reflex Test 3
Keywords: mutant allele gyrA 91F, wildtype allele gyrA 91S, ciprofloxacin-resistant Neisseria gonorrhoeae
Medical subject headings: Gonorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational Reflex Test 1Diagnostic test
Investigational Reflex Test 1
Investigational Reflex Test 2Diagnostic test
Investigational Reflex Test 2
Investigational Reflex Test 3Diagnostic test
Investigational Reflex Test 3

Study groups in NCT06815536
Study group	Role	What they receive
Urine		Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples. Receives: Diagnostic Test: Investigational Reflex Test 1; Diagnostic Test: Investigational Reflex Test 2; Diagnostic Test: Investigational Reflex Test 3
Vaginal Swab		Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs. Receives: Diagnostic Test: Investigational Reflex Test 1; Diagnostic Test: Investigational Reflex Test 2; Diagnostic Test: Investigational Reflex Test 3
Pharyngeal Swabs		Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs. Receives: Diagnostic Test: Investigational Reflex Test 1; Diagnostic Test: Investigational Reflex Test 2; Diagnostic Test: Investigational Reflex Test 3

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Number of invalid results for Investigational Reflex Test 1 in urine
Measured: One day
Number of invalid results for Investigational Reflex Test 1 in vaginal swabs
Measured: One day
Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs
Measured: One day
Number of invalid results for Investigational Reflex Test 2 in urine
Measured: One day
Number of invalid results for Investigational Reflex Test 2 in vaginal swabs
Measured: One day
Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs
Measured: One day
Number of invalid results for Investigational Reflex Test 3 in urine
Measured: One day
Number of invalid results for Investigational Reflex Test 3 in vaginal swabs
Measured: One day
Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 202531 Jul 2026

First posted7 Feb 2025
Study start16 Apr 2025
Primary completion31 Jul 2026
Study completion31 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neisseria Gonorrheae InfectionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 2,627 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06815536
Sponsor's protocol ID: Pro00113379
Other IDs: UM1AI104681
Acronym: MASTERMINDRING
Status last verified: Sep 2026
First submitted: 3 Feb 2025
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data (IPD) including clinical specimen details, investigational testing results, and sequencing results can be shared with other researchers after primary publication. Investigators must apply to the Antibacterial Resistance Group for approval to receive and use the data. Investigators must comply with additional contractual and regulatory obligations.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
ClinicalTrials.gov ID: NCT06815536
Acronym / sponsor ID: MASTERMINDRING / Pro00113379
Conditions: Neisseria Gonorrheae Infection
Keywords: mutant allele gyrA 91F, wildtype allele gyrA 91S, ciprofloxacin-resistant Neisseria gonorrhoeae
Study type: Observational
Recruitment status: Completed
Enrolment: 2,627 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), SpeeDx Pty Ltd, Abbott, Seegene USA Inc
Study start: 16 Apr 2025 (actual)
Primary completion: 31 Jul 2026 (actual)
Study completion: 31 Jul 2026 (actual)
First posted: 7 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Urine	–	Diagnostic Test: Investigational Reflex Test 1, Diagnostic Test: Investigational Reflex Test 2, Diagnostic Test: Investigational Reflex Test 3Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.
Vaginal Swab	–	Diagnostic Test: Investigational Reflex Test 1, Diagnostic Test: Investigational Reflex Test 2, Diagnostic Test: Investigational Reflex Test 3Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.
Pharyngeal Swabs	–	Diagnostic Test: Investigational Reflex Test 1, Diagnostic Test: Investigational Reflex Test 2, Diagnostic Test: Investigational Reflex Test 3Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Clinical specimens from male and females that test positive for Neisseria gonorrhoeae

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational Reflex Test 1Investigational Reflex Test 1	Diagnostic test	Pharyngeal Swabs, Urine, Vaginal Swab
Investigational Reflex Test 2Investigational Reflex Test 2	Diagnostic test	Pharyngeal Swabs, Urine, Vaginal Swab
Investigational Reflex Test 3Investigational Reflex Test 3	Diagnostic test	Pharyngeal Swabs, Urine, Vaginal Swab

Primary outcome

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.

9 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Individual participant dataSharing planned: Yes. Individual participant data (IPD) including clinical specimen details, investigational testing results, and sequencing results can be shared with other researchers after primary publication. Investigators must apply to the Antibacterial Resistance Group for approval to receive and use the data. Investigators must comply with additional contractual and regulatory obligations.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J. Satlin, MD, MS principal investigator

Weill Medical College of Cornell University

Jeffrey D. Klausner, MD, MPH principal investigator

University of Southern California - Los Angeles

Vance G. Fowler, MD, MHS study director

Duke University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neisseria Gonorrheae Infection, run by Duke University at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine (time frame: One day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06815536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.