SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

University of Washington1,800 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

1,800

Conditions

Neisseria Gonorrhoeae Infection

Interventions

Ciprofloxacin 500 mgDRUG

Ciprofloxacin 500 MG, taken once orally.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Public Health -- Seattle & King County Sexual Health Clinic

Seattle, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: 2 years

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

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

Time frame: 2 years

Secondary Outcomes

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

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

Time frame: 2 years

To determine time from screening to treatment using SpeeDx gyrA assay

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

Time frame: 2 years

Central Contacts

Angela LeClair

CONTACT

206-744-0489 achein@uw.edu

Data from ClinicalTrials.gov

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