Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.

Abstract

BACKGROUND:

Novel treatment strategies to slow the continued emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae are urgently needed. A molecular assay that predicts in vitro ciprofloxacin susceptibility is now available but has not been systematically studied in human infections.

METHODS:

Using a genotypic polymerase chain reaction assay to determine the status of the N. gonorrhoeae gyrase subunit A serine 91 codon, we conducted a multisite prospective clinical study of the efficacy of a single oral dose of ciprofloxacin 500 mg in patients with culture-positive gonorrhea. Follow-up specimens for culture were collected to determine microbiological cure 5-10 days post-treatment.

RESULTS:

Of the 106 subjects possessing culture-positive infections with wild-type gyrA serine N. gonorrhoeae genotype, the efficacy of single-dose oral ciprofloxacin treatment in the per-protocol population was 100% (95% 1-sided confidence interval, 97.5-100%).

CONCLUSIONS:

Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious. The widespread introduction and scale-up of gyrA serine 91 genotyping in N. gonorrhoeae infections could have substantial medical and public health benefits in settings where the majority of gonococcal infections are ciprofloxacin susceptible.

CLINICAL TRIALS REGISTRATION:

NCT02961751.

• Authors: Jeffrey D Klausner, Claire C Bristow, Olusegun O Soge, Akbar Shahkolahi, Toni Waymer, Robert K Bolan, Susan S Philip, Lenore E Asbel, Stephanie N Taylor, Leandro A Mena, Deborah A Goldstein, Jonathan A Powell, Michael R Wierzbicki, Sheldon R Morris
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 73 Issue 2 Pg. 298-303 (07 15 2021) ISSN: 1537-6591 [Electronic] United States
• PMID: 32766725 (Publication Type: Clinical Trial, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

Chemical References

• Anti-Bacterial Agents
• Ciprofloxacin

Topics

• Anti-Bacterial Agents (pharmacology, therapeutic use)
• Ciprofloxacin (therapeutic use)
• Drug Resistance, Bacterial
• Gonorrhea (drug therapy)
• Humans
• Microbial Sensitivity Tests
• Neisseria gonorrhoeae (genetics)
• Prospective Studies