Journal Article

The Efficacy and Safety of Gentamicin Plus Azithromycin and Gemifloxacin Plus Azithromycin as Treatment of Uncomplicated Gonorrhea

Moore, Page C., Papp, John R., Hook, Edward W., Philip, Susan S., Kerndt, Peter R., Johnson, Shacondra, Ghanem, Khalil G., Weinstock, Hillard S., Wiesenfeld, Harold C., Kirkcaldy, Robert D.

2014

Overview

Background. Ceftriaxone is the foundation of currently recommended gonorrhea treatment. There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin-resistant Neisseria gonorrhoeae. We evaluated the efficacy and tolerability of 2 combinations of existing non-cephalosporin antimicrobials for treatment of patients with urogenital gonorrhea. Methods. We conducted a randomized, multisite, open-label, noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama, California, Maryland, and Pennsylvania. Patients aged 15–60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally, or gemifloxacin 320 mg orally plus azithromycin 2 g orally. The primary outcome was microbiological cure of urogenital infections (negative follow-up culture) at 10–17 days after treatment among 401 participants in the per protocol population. Results. Microbiological cure was achieved by 100% (lower 1-sided exact 95% confidence interval [CI] bound, 98.5%) of 202 evaluable participants receiving gentamicin/azithromycin, and 99.5% (lower 1-sided exact 95% CI bound, 97.6%) of 199 evaluable participants receiving gemifloxacin/azithromycin. Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections. Gastrointestinal adverse events were common in both arms. Conclusions. Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea. Gastrointestinal adverse events may limit routine use. These non-cephalosporin-based regimens may be useful alternative options for patients who cannot be treated with cephalosporin antimicrobials. Additional treatment options for gonorrhea are needed. Clinical Trials Registration. NCT00926796.

• Publisher: OXFORD UNIVERSITY PRESS,Oxford University Press
• Subject: Administration, Oral / Adolescent / Adult / Allergies / and Commentaries / Anti-Bacterial Agents - adverse effects / Anti-Bacterial Agents - therapeutic use / Antimicrobial agents / Antimicrobials / ARTICLES AND COMMENTARIES / Azithromycin - adverse effects / Azithromycin - therapeutic use / Cephalosporins / Clinical trials / Disease transmission / Drug resistance / Drug therapy / Drug Therapy, Combination - adverse effects / Drug Therapy, Combination - methods / Drug-Related Side Effects and Adverse Reactions - epidemiology / Drug-Related Side Effects and Adverse Reactions - pathology / Effectiveness / Female / Fluoroquinolones - adverse effects / Fluoroquinolones - therapeutic use / Gastrointestinal Diseases - chemically induced / Gastrointestinal Diseases - epidemiology / Gastrointestinal Diseases - pathology / Gentamicins - adverse effects / Gentamicins - therapeutic use / Gonorrhea / Gonorrhea - drug therapy / Humans / Infections / Injections, Intramuscular / Male / Men / Middle Aged / Naphthyridines - adverse effects / Naphthyridines - therapeutic use / Neisseria gonorrhoeae / Neisseria gonorrhoeae - isolation & purification / Preventive medicine / Product safety / School enrollment / Sexually transmitted diseases / STD / Treatment Outcome / United States / Young Adult