SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

This study is looking at how well ciprofloxacin (500 mg, taken once orally) works to treat Neisseria gonorrhoeae (a sexually transmitted infection, also called Ng or gonorrhea). Researchers want to see if using a special test called the SpeeDx Resistance Plus assay, which checks for a specific gene change (gyrA mutation) in the bacteria, can help decide if ciprofloxacin will be an effective treatment. You might be able to join if you are 18 or older, speak English, have internet access, and are getting routine STI screening without active symptoms. The study aims to see how many people with a specific type of Ng infection (gyrA wildtype) are cured with ciprofloxacin over two years. The study plans to enroll 1800 people and its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 1800 participants.
What's involved
You will have specimens collected from areas of exposure for testing. If you are N. gonorrhoeae positive and have the gyrA wildtype, you will receive ciprofloxacin 500 mg orally once.
Compensation
Not stated in the trial record.
Follow-up
The effectiveness of the treatment will be measured at 2 years after receiving ciprofloxacin.

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NCT05286931

SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Recruiting
NAAges 18+Interventional
University of Washington
~1,800 participants
Updated 2022-03-18 on ClinicalTrials.gov
What's tested:Ciprofloxacin 500 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin
Measured over 2 years
+1 more outcome measured
Neisseria Gonorrhoeae Infection
1 sites across 1 states
Washington1
  • Lindley Barbee, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Washington

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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
  • Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin2 years

    Number and proportion of patients who test positive for Neisseria Gonorrhea (NG) and are gyrA wildtype of all patients enrolled/screened for NG

  • To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once2 years

    Number and proportion of NG-positive patients with gyrA wildtype who are cured (i.e. have negative test of cure results) with 500mg ciprofloxacin overall and by anatomic site