SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection
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.
Conditions:
🦠 Neisseria Gonorrhoeae Infection
🗓️ Study Start (Actual) 3 March 2022
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 1800
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 February 2022
  • First Submitted that Met QC Criteria 9 March 2022
  • First Posted 18 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 March 2022
  • Last Update Posted 18 March 2022
  • Last Verified March 2022