Development of New Antimicrobials for Urogenital Gonorrhea Therapy: Clinical Trial Design Considerations.
STD clinical trials
gonococcal antibiotic resistance
gonorrhea treatment
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
17 03 2020
17 03 2020
Historique:
received:
06
05
2019
accepted:
13
09
2019
pubmed:
21
9
2019
medline:
7
1
2021
entrez:
21
9
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31538646
pii: 5572069
doi: 10.1093/cid/ciz899
pmc: PMC7931841
doi:
Substances chimiques
Anti-Bacterial Agents
0
Anti-Infective Agents
0
Ceftriaxone
75J73V1629
Azithromycin
83905-01-5
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1495-1500Subventions
Organisme : NIAID NIH HHS
ID : HHSN272201300012C
Pays : United States
Informations de copyright
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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