RECRUITING

SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Conditions

Neisseria Gonorrhoeae Infection antimicrobial resistance ciprofloxacin molecular diagnostics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-03

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05286931

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* English speaking * Have access to the internet (via computer or phone) on at least a weekly basis * Asymptomatic (as defined below)	* 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

Inclusion Criteria

Exclusion Criteria

* English speaking
* Have access to the internet (via computer or phone) on at least a weekly basis
* Asymptomatic (as defined below)

* 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

Contacts and Locations

Study Contact

Angela LeClair

CONTACT

206-744-0489

achein@uw.edu

Principal Investigator

Lindley Barbee, MD, MPH

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

Public Health -- Seattle & King County Sexual Health Clinic

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: University of Washington

Lindley Barbee, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Washington

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 Registration Dates

Study Start Date2022-03-03

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-03-03

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

antimicrobial resistance
ciprofloxacin
molecular diagnostics

Additional Relevant MeSH Terms

Neisseria Gonorrhoeae Infection