Enabling Ciprofloxacin Resistance-Guided Therapy for Neisseria gonorrhoeae : Aligning Diagnostics, Regulation, Guidelines, and Reimbursement

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ID: 333466
2026
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Ranked #596 of 626 articles by views in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

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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.
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Authors Betsy Wonderly Trainor, Jennifer L. Osborn, Jeffrey David Klausner, Michael J. Satlin, Sarah N. Buss, Alicia Scheffer-Wong, Annette Harris, Barbara J. Van Der Pol, Carolyn D. Deal, Ashley Nenninger, Elisa Mokany, Kyung Moon, Joseph D. C. Yao, Lindley A. Barbee, Yonatan H. Grad, Richard A. Alm, Lao‐Tzu Allan‐Blitz, Deborah Godes, Elizabeth M. Marlowe, Scott R. Evans, Lauren Komarow, Stephanie E. McLaughlin, Brooke E Nichols, Robin Patel
Journal Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Year 2026
DOI
10.1093/cid/ciag640
URL
https://doi.org/10.1093/cid/ciag640
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