NCT06815536 · Duke University
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
(MASTERMINDRING)
What this study is about
The goal of this study is to learn if a few experimental tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
- Indianapolis, Indiana
- Jackson, Mississippi
- Royal Oak, Missouri
- Durham, North Carolina
- Salt Lake City, Utah
- Charlottesville, Virginia
- Vancouver, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations