SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

NCT05286931 | Recruiting DMC

• 1 other identifier: STUDY00012598
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Neisseria Gonorrhoeae Infection

Keywords

antimicrobial resistance; ciprofloxacin; molecular diagnostics

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• To confirm the SpeeDx gyrA Cipro-susceptibility prediction accuracy as compared to phenotypic susceptibility result

  2 years

• To determine time from screening to treatment using SpeeDx gyrA assay

  2 years

Study Arms (1)

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.

Drug: Ciprofloxacin 500 mg

Interventions

Ciprofloxacin 500 mg DRUG

Ciprofloxacin 500 MG, taken once orally.

N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Public Health -- Seattle & King County Sexual Health Clinic

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 17267635 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.

  PMID: 1987461 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.

  PMID: 28407640 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.

  PMID: 32766725 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.

  PMID: 32929456 BACKGROUND

MeSH Terms

Conditions

Gonorrhea

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lindley Barbee, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela LeClair

CONTACT

206-744-0489; achein@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Medicine Allergy and Infectious Diseases

Model Details: Prospective cohort

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 18, 2022
• Study Start: March 3, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)