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Fluoroquinolone Antibiotic

Ciprofloxacin Assay for Gonorrhea

N/A
Recruiting
Led By Lindley Barbee, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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
Contact to syphilis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 40 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test if a new test for Gonorrhea is better than the current standard at guiding treatment.

Who is the study for?
This trial is for English-speaking individuals who can access the internet weekly and are asymptomatic. It's not for those in contact with syphilis, unwilling to wait for test results before treatment, on certain antibiotics during the visit, showing symptoms of STIs (except some vaginitis), allergic to ciprofloxacin/ceftriaxone, or have taken antibiotics in the last 2 weeks.
What is being tested?
The study tests if using SpeeDx Resistance Plus assay can effectively guide treatment of gonorrhea at a sexual health clinic. Participants will be given Ciprofloxacin 500 mg based on their test results from this new method.
What are the potential side effects?
Ciprofloxacin may cause nausea, diarrhea, headaches, dizziness, and rarely more serious effects like tendon inflammation or nerve problems. Allergic reactions are possible but excluded by eligibility criteria.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have symptoms of a sexually transmitted infection other than vaginitis.
Select...
I have been exposed to syphilis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin
To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once
Secondary study objectives
To confirm the SpeeDx gyrA Cipro-susceptibility prediction accuracy as compared to phenotypic susceptibility result
To determine time from screening to treatment using SpeeDx gyrA assay

Side effects data

From 2008 Phase 1 trial • 24 Patients • NCT00785980
13%
Tinnitus
8%
Dizziness
8%
Ear discomfort
4%
Dysgeusia
4%
Headache
4%
Respiratory tract congestion
4%
Epistaxis
4%
Nausea
4%
Arthropod sting
4%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Quinine Sulfate Alone
Ciprofloxacin Alone
Quinine Sulfate With Ciprofloxacin

Awards & Highlights

Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment ArmExperimental Treatment1 Intervention
Participants who are N. gonorrhea (NG) positive and gyrA WT, will receive ciprofloxacin 500 mg PO x 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ciprofloxacin
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,912,583 Total Patients Enrolled
11 Trials studying Gonorrhea
39,253 Patients Enrolled for Gonorrhea
Lindley Barbee, MD, MPHPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Gonorrhea
32 Patients Enrolled for Gonorrhea

Media Library

Ciprofloxacin (Fluoroquinolone Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05286931 — N/A
Gonorrhea Research Study Groups: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm
Gonorrhea Clinical Trial 2023: Ciprofloxacin Highlights & Side Effects. Trial Name: NCT05286931 — N/A
Ciprofloxacin (Fluoroquinolone Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05286931 — N/A
~520 spots leftby Dec 2025
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