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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 • NCT0078598013%
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
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
1,740 Previous Clinical Trials
1,845,870 Total Patients Enrolled
7 Trials studying Gonorrhea
34,580 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken antibiotics in the last 2 weeks.I do not have symptoms of a sexually transmitted infection other than vaginitis.I have been exposed to syphilis.I do not have any symptoms.I am not taking metronidazole, fluconazole, or clotrimazole.
Research Study Groups:
This trial has the following groups:- Group 1: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 40 Other Conditions - This treatment demonstrated efficacy for 40 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At full capacity, how many people will be included in this experiment?
"The answer is affirmative. Currently, the clinical trial is looking for 1800 individuals from a single site. The trial was first posted on March 3rd, 2020 and was last edited on March 9th, 2020."
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