{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T12:35:21Z","timestamp":1769603721106,"version":"3.49.0"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2019,9,20]],"date-time":"2019-09-20T00:00:00Z","timestamp":1568937600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["HHSN272201300012"],"award-info":[{"award-number":["HHSN272201300012"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,3,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>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.<\/jats:p>","DOI":"10.1093\/cid\/ciz899","type":"journal-article","created":{"date-parts":[[2019,9,13]],"date-time":"2019-09-13T19:30:36Z","timestamp":1568403036000},"page":"1495-1500","source":"Crossref","is-referenced-by-count":15,"title":["Development of New Antimicrobials for Urogenital Gonorrhea Therapy: Clinical Trial Design Considerations"],"prefix":"10.1093","volume":"70","author":[{"suffix":"III","given":"Edward W","family":"Hook","sequence":"first","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lori","family":"Newman","sequence":"additional","affiliation":[{"name":"National Institute for Allergy and Infectious Diseases, Rockville, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Drusano","sequence":"additional","affiliation":[{"name":"Institute for Therapeutic Innovation, University of Florida, Lake Nona, Florida, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott","family":"Evans","sequence":"additional","affiliation":[{"name":"Milken Institute School of Public Health George Washington University, Washington, DC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H Hunter","family":"Handsfield","sequence":"additional","affiliation":[{"name":"University of Washington, Seattle, Washington, DC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann E","family":"Jerse","sequence":"additional","affiliation":[{"name":"Uniformed Services University, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabian Y S","family":"Kong","sequence":"additional","affiliation":[{"name":"Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeannette Y","family":"Lee","sequence":"additional","affiliation":[{"name":"University of Arkansas, Little Rock, Arkansas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie N","family":"Taylor","sequence":"additional","affiliation":[{"name":"Louisiana State Health Sciences Center, New Orleans, Louisiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolyn","family":"Deal","sequence":"additional","affiliation":[{"name":"National Institute for Allergy and Infectious Diseases, Rockville, Maryland, 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