SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT05286931

Collaborator

(none)

1,800

Enrollment

Location

Arm

Anticipated Duration (Months)

31.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neisseria Gonorrhoeae Infection	Drug: Ciprofloxacin 500 mg	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1800 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective cohortProspective cohort

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 3, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm Participants who are N. gonorrhea (NG) positive and gyrA WT, will receive ciprofloxacin 500 mg PO x 1.	Drug: Ciprofloxacin 500 mg Ciprofloxacin 500 MG, taken once orally.

Arm

Intervention/Treatment

Experimental: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm

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

Drug: Ciprofloxacin 500 mg

Ciprofloxacin 500 MG, taken once orally.

Outcome Measures

Primary Outcome Measures

Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin [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
To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once [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 Outcome Measures

To confirm the SpeeDx gyrA Cipro-susceptibility prediction accuracy as compared to phenotypic susceptibility result [2 years]
Percent concordance of gyrA result (molecular diagnostic) and the ciprofloxacin minimal inhibitory concentration (MIC) (aka. phenotypic antimicrobial susceptibility testing)
To determine time from screening to treatment using SpeeDx gyrA assay [2 years]
Number of days between screening and treatment by treatment group (Ciprofloxacin or Standard of care)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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