Health TrialsbyHealthPanel

SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

ConditionNeisseria Gonorrhoeae Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

Have access to the internet (via computer or phone) on at least a weekly basis

Asymptomatic (as defined below)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ciprofloxacin 500 mg

    Drug

    Ciprofloxacin 500 MG, taken once orally.

Treatment groups

1,800 Participants
are divided into 1 treatment group
Group A: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin

Number and proportion of patients who test positive for Neisseria Gonorrhea (NG) and are gyrA wildtype of all patients enrolled/screened for NG

Time frame
2 years
2

To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once

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

Time frame
2 years

Secondary outcomes

1

To confirm the SpeeDx gyrA Cipro-susceptibility prediction accuracy as compared to phenotypic susceptibility result

Percent concordance of gyrA result (molecular diagnostic) and the ciprofloxacin minimal inhibitory concentration (MIC) (aka. phenotypic antimicrobial susceptibility testing)

Time frame
2 years
2

To determine time from screening to treatment using SpeeDx gyrA assay

Number of days between screening and treatment by treatment group (Ciprofloxacin or Standard of care)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Source ClinicalTrials.gov
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