Development of New Antimicrobials for Urogenital Gonorrhea Therapy: Clinical Trial Design Considerations

Abstract Gonorrhea remains a major public health challenge, and current recommendations for gonorrhea treatment are threatened by evolving antimicrobial resistance and a diminished pipeline for new antibiotics. Evaluations of potential new treatments for gonorrhea currently make limited use of new u...

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Bibliographic Details
Published in:Clinical infectious diseases 2020-03, Vol.70 (7), p.1495-1500
Main Authors: Hook, Edward W, Newman, Lori, Drusano, George, Evans, Scott, Handsfield, H Hunter, Jerse, Ann E, Kong, Fabian Y S, Lee, Jeannette Y, Taylor, Stephanie N, Deal, Carolyn
Format: Article
Language:English
Subjects:
Adolescent
Anti-Bacterial Agents - pharmacology
Anti-Bacterial Agents - therapeutic use
Anti-Infective Agents - pharmacology
Azithromycin - pharmacology
Azithromycin - therapeutic use
Ceftriaxone - pharmacology
Ceftriaxone - therapeutic use
Clinical Trials as Topic
Drug Resistance, Bacterial
Female
Gonorrhea - drug therapy
Humans
Microbial Sensitivity Tests
Neisseria gonorrhoeae
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Summary:Abstract Gonorrhea remains a major public health challenge, and current recommendations for gonorrhea treatment are threatened by evolving antimicrobial resistance and a diminished pipeline for new antibiotics. Evaluations of potential new treatments for gonorrhea currently make limited use of new understanding of the pharmacokinetic and pharmacodynamic contributors to effective therapy, the prevention of antimicrobial resistance, and newer designs for clinical trials. They are hampered by the requirement to utilize combination ceftriaxone/azithromycin therapy as the comparator regimen in noninferiority trials designed to seek an indication for gonorrhea therapy. Evolving gonococcal epidemiology and clinical trial design constraints hinder the enrollment of those populations at the greatest risk for gonorrhea (adolescents, women, and persons infected with antibiotic-resistant Neisseria gonorrhoeae). This article summarizes a recent meeting on the evaluation process for antimicrobials for urogenital gonorrhea treatment and encourages the consideration of new designs for the evaluation of gonorrhea therapy. For more than 4 decades, clinical trial design for evaluation and regulatory approval of new antimicrobials for gonorrhea therapy have changed little. Evolving epidemiology, pharmacokinetic/pharmacodynamic science, and clinical trial methodology warrant reevaluations of clinical trial designs for gonorrhea treatment trials.
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/ciz899