Clinical Infectious Diseases· 2026Q1
Enabling Ciprofloxacin Resistance-Guided Therapy for Neisseria gonorrhoeae : Aligning Diagnostics, Regulation, Guidelines, and Reimbursement
- 1citations
- Q1SCImago
- 2026year
Short summary
Molecular tests predicting ciprofloxacin resistance in Neisseria gonorrhoeae could enable the use of oral ciprofloxacin for susceptible infections, reducing reliance on intramuscular ceftriaxone.
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Key points
- Ciprofloxacin resistance in N. gonorrhoeae is primarily caused by a single gyrA mutation at codon 91.
- Molecular tests can reliably predict ciprofloxacin resistance/susceptibility based on this mutation.
- A multicenter study is generating regulatory-grade data for FDA submissions of nucleic acid amplification tests.
- Implementing ciprofloxacin-guided therapy requires integration across diagnostics, regulation, guidelines, and reimbursement.
AI-generated from the title and abstract; the full text is not read.
Abstract
Abstract Gonorrhea treatment in the United States relies on empirically administered intramuscular ceftriaxone. Diagnostics to predict Neisseria gonorrhoeae ciprofloxacin susceptibility/resistance could enable use of ciprofloxacin, a low-cost, single-dose oral antibiotic, to treat ciprofloxacin-susceptible gonorrhea. Ciprofloxacin resistance in N. gonorrhoeae is overwhelmingly mediated by a single mutation in gyrA at codon 91. Molecular interrogation of this site reliably predicts ciprofloxacin resistance and susceptibility. The Antibacterial Resistance Leadership Group (ARLG) is performing a multicenter, multicompany study to generate regulatory-grade clinical performance data to support Food and Drug Administration submissions of multiple nucleic acid amplification tests to predict ciprofloxacin susceptibility in N. gonorrhoeae. In December 2025, a multidisciplinary group was convened by the ARLG and Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator to discuss a coordinated pathway to enable individualized ciprofloxacin resistance-guided gonorrhea therapy in the United States, acknowledging this will require integration across diagnostics, regulation, guidelines, reimbursement, and implementation. Meeting highlights are presented.
The authors' abstract, as published at the source. Clinical Infectious Diseases, 2026 · DOI ↗
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