Clinical trial NCT05286931: SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection
Official title: Evaluation of SpeeDx's Ciprofloxacin gyrA Assay for Clinical Care of STD Clinic Patients With Neisseria Gonorrhea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neisseria Gonorrhoeae Infection
Keywords: antimicrobial resistance
ciprofloxacin
molecular diagnostics
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* English speaking
* Have access to the internet (via computer or phone) on at least a weekly basis
* Asymptomatic (as defined below)

Exclusion Criteria:

* 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
* Anyone receiving a gonococcal-active drug (such as Doxycycline, Penicillin, Ceftriaxone) during the visit. Those receiving metronidazole, fluconazole, or clotrimazole will not be excluded.
* Known allergy to ciprofloxacin and/or ceftriaxone

Primary outcomes:
measure: Determine the number and proportion of Neisseria Gonorrhea (NG) cases that can be cured with ciprofloxacin
timeFrame: 2 years
measure: To determine the effectiveness of treating patients with Neisseria Gonorrhea gyrA wildtype with Ciprofloxacin 500 mg orally once
timeFrame: 2 years
Secondary outcomes:
measure: To confirm the SpeeDx gyrA Cipro-susceptibility prediction accuracy as compared to phenotypic susceptibility result
timeFrame: 2 years
measure: To determine time from screening to treatment using SpeeDx gyrA assay
timeFrame: 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Public Health -- Seattle & King County Sexual Health Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Lindley Barbee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.