SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

Neisseria Gonorrhoeae Infection Clinical Trial

Official title:

Evaluation of SpeeDx's Ciprofloxacin gyrA Assay for Clinical Care of STD Clinic Patients With Neisseria Gonorrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286931
• Other study ID #: STUDY00012598
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2022
• Source: University of Washington
• Contact: Angela LeClair
• Phone: 206-744-0489
• Email: achein[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gonorrhea
• Infections
• Neisseria Gonorrhoeae Infection

Intervention

Drug:
• Ciprofloxacin 500 mg
Ciprofloxacin 500 MG, taken once orally.

Locations

Country	Name	City	State
United States	Public Health -- Seattle & King County Sexual Health Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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® 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. — View Citation

Hooper DC, Wolfson JS. Fluoroquinolone antimicrobial agents. N Engl J Med. 1991 Feb 7;324(6):384-94. Review. — View 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. Erratum in: Clin Infect Dis. 2021 Mar 1;72(5):911. — View 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. Epub 2007 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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)	2 years