Testing a new assay to guide treatment for gonorrhea infections
Evaluation of SpeeDx's Ciprofloxacin gyrA Assay for Clinical Care of STD Clinic Patients With Neisseria Gonorrhea
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05286931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include asymptomatic individuals seeking STI screening or those with known exposure to gonorrhea.
Not a fit: Patients with active urogenital symptoms or those who have recently used antibiotics may not benefit from this study.
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 performed: Other studies have shown promise in using molecular diagnostics to guide treatment for STIs, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.