SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05286931
Status
Recruiting

Conditions

  • Neisseria Gonorrhoeae Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ciprofloxacin 500 mg — DRUG
    Ciprofloxacin 500 MG, taken once orally.

Study Details

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.

Key Dates

Start date
Mar 3, 2022
Status verified
Mar 2022
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
1,800 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Public Health -- Seattle & King County Sexual Health ClinicSeattleWashington98104
Angela LeClair, ND

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