SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Neisseria Gonorrhoeae Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ciprofloxacin 500 mg

Intervention Type DRUG

Ciprofloxacin 500 MG, taken once orally.

Interventions

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Ciprofloxacin 500 mg

Ciprofloxacin 500 MG, taken once orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes