Status:
RECRUITING
SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection
Lead Sponsor:
University of Washington
Conditions:
Neisseria Gonorrhoeae Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Patients entering the Sexual Health Clinic will be offered participation in the study if they have; 1) no infectious genitourinary symptoms that require immediate treatment, 2) who seek routine STI sc...
Eligibility Criteria
Inclusion
- English speaking
- Have access to the internet (via computer or phone) on at least a weekly basis
- Asymptomatic (as defined below)
Exclusion
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT05286931
Start Date
March 3 2022
End Date
December 31 2026
Last Update
March 18 2022
Active Locations (1)
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1
Public Health -- Seattle & King County Sexual Health Clinic
Seattle, Washington, United States, 98104