RecruitingNot ApplicableNCT05286931

SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Evaluation of SpeeDx's Ciprofloxacin gyrA Assay for Clinical Care of STD Clinic Patients With Neisseria Gonorrhea


Sponsor

University of Washington

Enrollment

1,800 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • English speaking
  • Have access to the internet (via computer or phone) on at least a weekly basis
  • Asymptomatic (as defined below)

Exclusion Criteria6

  • 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

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Interventions

DRUGCiprofloxacin 500 mg

Ciprofloxacin 500 MG, taken once orally.


Locations(1)

Public Health -- Seattle & King County Sexual Health Clinic

Seattle, Washington, United States

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NCT05286931