An interventional study of Ciprofloxacin 500 mg in Neisseria Gonorrhoeae Infection, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by University of Washington · Not applicable, Interventional, and Other
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.
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).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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.
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
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
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
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
Plan to share: No
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