Diagnostic Tests for Ciprofloxacin-Resistant Gonorrhea

(MASTERMINDRING Trial)

Recruiting at 7 trial locations

Overseen By Nyssa Schwager, MSN, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Specimen media incompatible, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

3291 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new diagnostic methods to determine if they can accurately detect a specific gene mutation linked to antibiotic resistance in gonorrhea. The goal is to assess whether these tests can correctly identify the gene mutation that makes gonorrhea resistant to ciprofloxacin, an antibiotic. Researchers will use urine, throat, and vaginal swabs to compare results against a standard gene sequencing method. Individuals diagnosed with gonorrhea who have sufficient sample material for testing may be suitable candidates for this study. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could enhance diagnostic methods for antibiotic-resistant infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on testing specimens for a gene mutation related to ciprofloxacin resistance.

What prior data suggests that these investigational tests are safe?

Research has shown that reflex tests, like those in this study, are generally safe. For the urine reflex test, studies indicate that chemical analysis identifies problems quickly and without known risks when performed correctly.

Pharyngeal swab tests are common and widely used, involving throat samples. They are standard in medical settings, with no significant safety concerns reported.

Similarly, vaginal swab tests routinely check for infections. They are safe and provide quick results.

Overall, these tests are well-tolerated and carry minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to develop a more precise way to diagnose ciprofloxacin-resistant Neisseria gonorrhoeae. Unlike current methods that might not immediately identify antibiotic resistance, this trial uses an investigational reflex test to detect specific genetic markers—mutant gyrA 91F or wildtype gyrA 91S alleles—through urine, pharyngeal, and vaginal samples. This targeted approach could lead to quicker, more accurate diagnoses, allowing for more effective treatment plans and helping to combat antibiotic resistance.

What evidence suggests that these investigational reflex tests are effective for detecting ciprofloxacin resistance in Neisseria gonorrhoeae?

Research shows that the new reflex tests in this trial aim to identify specific gene changes in Neisseria gonorrhoeae, the bacteria that cause gonorrhea. These changes indicate resistance to ciprofloxacin, a common antibiotic. Participants will undergo various investigational reflex tests using different sample types, such as urine, pharyngeal swabs, and vaginal swabs, to detect a specific gene change called the gyrA 91F allele. Early studies have demonstrated that these tests can successfully identify these changes, which is crucial for selecting the appropriate treatment. The results suggest that using these tests could help doctors avoid prescribing ineffective antibiotics. ^{3 6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have enough sample for gonorrhea testing and genetic analysis.

I tested positive for gonorrhea with an FDA-approved test.

I can store and handle my medication properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Specimen Collection

Collection of urine, vaginal swab, and pharyngeal swab specimens for testing

1 day

1 visit (in-person)

Diagnostic Testing

Specimens are tested using investigational reflex tests and Sanger sequencing to detect gyrA mutations

1 day

Follow-up

Participants are monitored for any adverse events and results are analyzed

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Reflex Test 1
• Investigational Reflex Test 2
• Investigational Reflex Test 3

How Is the Trial Designed?

Group I: Vaginal Swab Experimental Treatment 3 Interventions

Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs.

Group II: Urine Experimental Treatment 3 Interventions

Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples.

Group III: Pharyngeal Swabs Experimental Treatment 3 Interventions

Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

SpeeDx Pty Ltd

Industry Sponsor

Trials

3

Recruited

5,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Seegene USA Inc

Collaborator

Trials

1

Recruited

3,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10071290/

Neisseria gonorrhoeae diagnostic escape from a gyrA ... The aim of this study was to investigate the possibility of diagnostic escape from gyrA susceptibility testing.

2. trial.medpath.com trial.medpath.com/clinical-trial/97a8dfd007a3e0d3/ciprofloxacin-resistant-neisseria-gonorrhoeae-diagnostics

Master Protocol for Evaluating Multiple Infection Diagnostics ... The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02961751?cond=Gonorrhea&viewType=Table&term=CIPROFLOXACIN&rank=2&tab=results

Study Results | Clinical Validation of a Molecular Test for ... A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different ...

4. researchgate.net researchgate.net/publication/343540203_Resistance-Guided_Treatment_of_Gonorrhea_A_Prospective_Clinical_Study

Resistance-Guided Treatment of Gonorrhea: A Prospective ... The test consists of a multiplex quantitative PCR (qPCR), incorporating channels for the wild-type gyrA allele encoding 91S, the mutant gyrA ...

5. biorxiv.org biorxiv.org/content/10.1101/2022.08.10.503517v2.full-text

Neisseria gonorrhoeae diagnostic escape from a gyrA ... In this study, we investigated the pathways of diagnostic escape from tests that rely on GyrA 91. We found that some clinical isolates with a ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/condition/317/vaginal-infection

Vaginal Infection Clinical Research Trials The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance ...

7. dash.harvard.edu dash.harvard.edu/bitstreams/562d332a-fa67-47c0-bb9b-d2f41f756d9d/download

Mechanisms and acquisition of antibiotic resistance in N ... A vaccine can be safe, cheap, stable, and efficacious against a broad range of strains, but provides the added benefit of preventing disease ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4609686/

Detection of Neisseria gonorrhoeae Isolates from Tonsils and ... N. gonorrhoeae was reisolated from tonsils (62%) and oropharynx (52%) using culture. NAAT detected it in 84% of tonsils and 81% of oropharynx samples.

9. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9I3NLI0tzEx1Dc1NLI3MzCwMQ0FHKSy4xMDMDyphbKsUCAJLTFq4-

Save Selected ... gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the ...