NCT05286931 SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection
| NCT ID | NCT05286931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Neisseria Gonorrhoeae Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,800 participants in total. It began in 2022-03-03 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to test the effectiveness of using of SpeeDx Resistance Plus assay to guide treatment of Neisseria gonorrhoeae (Ng) in a sexual health clinic setting.
Eligibility 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
Contact & Investigator
Lindley Barbee, MD, MPH
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05286931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neisseria Gonorrhoeae Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05286931 currently recruiting?
Yes, NCT05286931 is actively recruiting participants. Contact the research team at achein@uw.edu for enrollment information.
Where is the NCT05286931 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05286931 clinical trial?
NCT05286931 is sponsored by University of Washington. The principal investigator is Lindley Barbee, MD, MPH at University of Washington. The trial plans to enroll 1,800 participants.