NCT05286931

SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Neisseria Gonorrhoeae Infection

Interventions

Type	Name	Description
DRUG	Ciprofloxacin 500 mg	Ciprofloxacin 500 MG, taken once orally.

Timeline

• Start date: 2022-03-03
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-03-18
• Last updated: 2022-03-18

Locations

1 site across 1 country: United States