Evidence map›Paper›PMID 39045871›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.

Hiwot Hiruy, Shukal Bala, James M Byrne, Kerian Grande Roche, Seong H Jang, Peter Kim, Sumathi Nambiar, Dan Rubin, Yuliya Yasinskaya, Laura H Bachmann and 25 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. PreclinicalFrontiers in immunology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors.

Hiwot HiruyDivision of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Shukal BalaDivision of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
James M ByrneOffice of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, Maryland, USA.
Kerian Grande RocheDivision of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Seong H JangDivision of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA.
Peter KimDivision of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Sumathi NambiarDivision of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Dan RubinDivision of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA.
Yuliya YasinskayaDivision of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Laura H BachmannDivision of STD Prevention, National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Kyle BernsteinDivision of STD Prevention, NCHHSTP, CDC, Atlanta, Georgia, USA.
Radu BotgrosOffice of Biological Health Threats and Vaccines Strategy, Clinical Studies and Manufacturing Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Sue CammarataDepartment of Clinical Development, Melinta Therapeutics, Parsippany, New Jersey, USA.
Ricardo L ChavesDepartment of Clinical Development, Debiopharm International SA, Lausanne, Switzerland.
Carolyn D DealEnteric and Sexually Transmitted Infections Branch, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.
George L DrusanoInstitute for Therapeutic Innovation, College of Medicine, University of Florida, Lake Nona, Florida, USA.
Erin M DuffyCombating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University, Boston, Massachusetts, USA.
Ann E EakinOffice of Biodefense, Research Resources & Translational Research, DMID, NIAID, NIH, Bethesda, Maryland, USA.
Steve GeloneOffice of the President - Clinical Research and Development, Nabriva Therapeutics plc, Fort Washington, Pennsylvania, USA.
Thomas HiltkeEnteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Bethesda, Maryland, USA.
Edward W HookDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Ann E JerseDepartment of Microbiology and Immunology, Uniformed Services University, Bethesda, Maryland, USA.
Candice J McNeilDepartment of Medicine, Section on Infectious Diseases, Wake Forest University School of Medicine, Southeast STD/HIV PTC, Forsyth County Department of Public Health, and North Carolina Strengthening the United States Response to Resistant Gonorrhea, Winston-Salem, North Carolina, USA.
Lori NewmanEnteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Rockville, Maryland, USA.
Seamus O'BrienDirector- Research and Development, Global Antibiotic Research & Development Partnership, Geneva, Switzerland.
Caroline PerryDepartment of Clinical Research and Early Programs, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Hilary E L RenoWashington University School of Medicine in St. Louis, St. Louis STD/HIV Prevention Training Center, St. Louis STI Regional Response Coalition, St. Louis, Missouri, USA.
Raul A RomagueraDivision of STD Prevention, NCHHSTP, CDC, Atlanta, Georgia, USA.
Junko SatoOffice of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
Magnus UnemoWorld Health Organization (WHO) Collaborating Centre for Gonorrhea and Other STIs, Örebro University, Örebro, Sweden.
Teodora E C WiGlobal HIV, Hepatitis and STIs Programmes, WHO, Geneva, Switzerland.
Kimberly WorkowskiDepartment of Medicine, Emory University, Atlanta, Georgia, USA.
Graeme A O'MayDRT Strategies, Inc, Arlington, Virginia, USA.
Sunita J ShuklaOffice of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, Maryland, USA.
John J FarleyOffice of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, Maryland, USA.

Funding

Administration for Strategic Preparedness and ResponseBiomedical Advanced Research and Development Authority 75A50122C00028BMBFCARB-XCenter for Drug Evaluation and ResearchFederal Ministry of Education and ResearchFederal Republic of GermanyUS Department of Health and Human ServicesUS FDAWellcome Trust WT224842World Health Organization 001
6 · The paper itself

Abstract

There is an unmet need for developing drugs for the treatment of gonorrhea due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug-resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On 23 April 2021, the US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institute of Allergy and Infectious Diseases of the National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of that workshop.

Indexed as

Anti-Bacterial AgentsDrug DevelopmentGonorrheaCenters for Disease Control and Prevention, U.S.Clinical Trials as TopicHumansNational Institutes of Health (U.S.)Neisseria gonorrhoeaeUnited StatesUnited States Food and Drug AdministrationAnti-Bacterial Agentsantimicrobial drugsantimicrobial resistancedrug developmentgonorrheaunmet need

Identifiers

PMID39045871
PMCPMC13370471

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.