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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm | Experimental | Participants who are N. gonorrhea (NG) positive and gyrA WT, will receive ciprofloxacin 500 mg PO x 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin 500 mg | Drug | Ciprofloxacin 500 MG, taken once orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years |
| To determine time from screening to treatment using SpeeDx gyrA assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela LeClair | Contact | 206-744-0489 | achein@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lindley Barbee, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health -- Seattle & King County Sexual Health Clinic | Recruiting | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17267635 | Background | Siedner MJ, Pandori M, Castro L, Barry P, Whittington WL, Liska S, Klausner JD. Real-time PCR assay for detection of quinolone-resistant Neisseria gonorrhoeae in urine samples. J Clin Microbiol. 2007 Apr;45(4):1250-4. doi: 10.1128/JCM.01909-06. Epub 2007 Jan 31. | |
| 1987461 | Background | Hooper DC, Wolfson JS. Fluoroquinolone antimicrobial agents. N Engl J Med. 1991 Feb 7;324(6):384-94. doi: 10.1056/NEJM199102073240606. No abstract available. |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Prospective cohort
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Number of days between screening and treatment by treatment group (Ciprofloxacin or Standard of care) |
| 2 years |
| 28407640 | Background | Allan-Blitz LT, Wang X, Klausner JD. Wild-Type Gyrase A Genotype of Neisseria gonorrhoeae Predicts In Vitro Susceptibility to Ciprofloxacin: A Systematic Review of the Literature and Meta-Analysis. Sex Transm Dis. 2017 May;44(5):261-265. doi: 10.1097/OLQ.0000000000000591. |
| 32766725 | Background | Klausner JD, Bristow CC, Soge OO, Shahkolahi A, Waymer T, Bolan RK, Philip SS, Asbel LE, Taylor SN, Mena LA, Goldstein DA, Powell JA, Wierzbicki MR, Morris SR. Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study. Clin Infect Dis. 2021 Jul 15;73(2):298-303. doi: 10.1093/cid/ciaa596. |
| 32929456 | Background | Hadad R, Cole MJ, Ebeyan S, Jacobsson S, Tan LY, Golparian D, Erskine S, Day M, Whiley D, Unemo M; European collaborative group. Evaluation of the SpeeDx ResistancePlus(R) GC and SpeeDx GC 23S 2611 (beta) molecular assays for prediction of antimicrobial resistance/susceptibility to ciprofloxacin and azithromycin in Neisseria gonorrhoeae. J Antimicrob Chemother. 2021 Jan 1;76(1):84-90. doi: 10.1093/jac/dkaa381. |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |