SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

March 9, 2022 updated by: Lindley Barbee, University of Washington

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Angela LeClair
  • Phone Number: 206-744-0489
  • Email: achein@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Public Health -- Seattle & King County Sexual Health Clinic
        • Contact:
          • Angela LeClair, ND

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin
Time Frame: 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
2 years
To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once
Time Frame: 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
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00012598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neisseria Gonorrhoeae Infection

Clinical Trials on Ciprofloxacin 500 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe