Testing a new assay to guide treatment for gonorrhea infections
Official title: Evaluation of SpeeDx's Ciprofloxacin gyrA Assay for Clinical Care of STD Clinic Patients With Neisseria Gonorrhea
Run by University of Washington · NCT05286931 · Data updated 2026-11-12
This study is testing a new test to see if it can help doctors choose the best treatment for gonorrhea infections in patients at a sexual health clinic.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1800 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | March 3, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | March 18, 2022 |
| Trial ID | NCT05286931 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include asymptomatic individuals seeking STI screening or those with known exposure to gonorrhea.
✕Probably not a fit
Patients with active urogenital symptoms or those who have recently used antibiotics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the SpeeDx Resistance Plus assay in guiding treatment for Neisseria gonorrhoeae infections in a sexual health clinic. Patients seeking routine STI screening or those with specific risk factors will be invited to participate. Specimens will be collected for nucleic acid amplification testing (NAAT) and culture, with positive results further analyzed for ciprofloxacin resistance. Depending on the assay results, participants will receive either ciprofloxacin or standard ceftriaxone therapy.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment strategies for gonorrhea, reducing the impact of antimicrobial resistance.
How similar studies have gone: Other studies have shown promise in using molecular diagnostics to guide treatment for STIs, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * English speaking * Have access to the internet (via computer or phone) on at least a weekly basis * Asymptomatic (as defined below) Exclusion Criteria: * Urogenital symptoms consistent with a sexual transmitted infection (other than vaginitis associated with trichomonas vaginalis, bacterial vaginosis or yeast). Symptoms consistent with cervicitis, urethritis, or PID will not be offered enrollment. * Antibiotic use within the last 2 weeks * Contact to syphilis * Contact to an STI and are unwilling to defer empiric treatment until diagnostic test results return * Anyone receiving a gonococcal-active drug (such as Doxycycline, Penicillin, Ceftriaxone) during the visit. Those receiving metronidazole, fluconazole, or clotrimazole will not be excluded. * Known allergy to ciprofloxacin and/or ceftriaxone
Where it's running
-
Public Health -- Seattle & King County Sexual Health Clinic
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Lindley Barbee, MD, MPH — University of Washington
- Study coordinator: Angela LeClair
- Email: achein@uw.edu
- Phone: 206-744-0489
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.