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NCT Number: NCT05286931

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health -- Seattle & King County Sexual Health Clinic

Seattle, Washington, 98104, United States

Location status: Recruiting

Location contact

Angela LeClair, ND

CONTACT

About this study

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 screening, 3) if they report sexual contact with a partner who reports having Ng or 4) men who have sex with men (MSM) with contact to chlamydia trachomatis (CT).

All participants will have specimen collected from anatomical sites of exposure for NAAT and culture. NAAT specimen positive for Ng will be flagged and further tested with SpeeDx Resistance Plus assay. This will delay results reporting on average by 1 day. The assay detects Ciprofloxacin resistance based on a point mutation of the gyrA gene (gyrA s91). Participants without this mutation or wild-type (gyrA WT) infection should be sensitive to Ciprofloxacin.

Participants who are N. gonorrhoeae (NG) positive and gyrA WT, will receive ciprofloxacin 500 mg PO x 1.

Participants with gyrA s91 mutation will be asked to return to clinic for the standard of care (i.e. ceftriaxone-based therapy).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciprofloxacin 500 mg

Drug

Ciprofloxacin 500 MG, taken once orally.

Primary outcomes

  1. Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin

    Time frame: 2 years

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

  2. To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once

    Time frame: 2 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

Secondary outcomes

  1. To confirm the SpeeDx gyrA Cipro-susceptibility prediction accuracy as compared to phenotypic susceptibility result

    Time frame: 2 years

    Percent concordance of gyrA result (molecular diagnostic) and the ciprofloxacin minimal inhibitory concentration (MIC) (aka. phenotypic antimicrobial susceptibility testing)

  2. To determine time from screening to treatment using SpeeDx gyrA assay

    Time frame: 2 years

    Number of days between screening and treatment by treatment group (Ciprofloxacin or Standard of care)

Study contacts

Contact information is provided by the study sponsor or research team.

Angela LeClair

CONTACT

[email protected]

206-744-0489

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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