SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

University of Washington

Status

Enrolling

Conditions

Neisseria Gonorrhoeae Infection

Treatments

Drug: Ciprofloxacin 500 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05286931

STUDY00012598

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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