Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02294682 (A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae), which is not on this map. Cited by 88 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
Who cites it
88 citing papers in PubMed, 3 syntheses or guidelines pooled it, 164 citations in OpenAlex.
- Efficacy and safety of Gepotidacin for urogenital infections: a systematic review and meta-analysis of randomized controlled trials.Infection · 2026Pooled it
- A systematic review of antimicrobial resistance in Neisseria gonorrhoeae and Mycoplasma genitalium in sub-Saharan Africa.The Journal of antimicrobial chemotherapy · 2022Pooled it
- Aztreonam for Neisseria gonorrhoeae: a systematic review and meta-analysis.The Journal of antimicrobial chemotherapy · 2020Pooled it
- Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects.Clinical and translational science · 2022Trial
- Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants.Antimicrobial agents and chemotherapy · 2022Trial
- Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis).Antimicrobial agents and chemotherapy · 2020Trial
- Microbiological Analysis from a Phase 2 Randomized Study in Adults Evaluating Single Oral Doses of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae.Antimicrobial agents and chemotherapy · 2018Trial
- Measuring the health benefits and costs of antimicrobial-resistant gonorrhea surveillance in the United States: an agent-based model and cost-effectiveness analysis.Lancet regional health. Americas · 2026Article
- Simulating treatment effects for gonorrhoea using a within-host mathematical model.Infectious Disease Modelling · 2026Article
- Genetic Background Modulates Zoliflodacin and Gepotidacin Cross-Resistance and Fitness in Neisseria gonorrhoeae.The Journal of infectious diseases · 2026Article
- Antimicrobial resistance crisis in STIs: Gonorrhea andNew microbes and new infections · 2026Review
- Fluoroquinolone resistance-conferringbioRxiv : the preprint server for biology · 2026Article
- Stepwise evolution and clonal enrichment of gepotidacin resistance inAntimicrobial agents and chemotherapy · 2026Article
- A new chapter in STI management: gepotidacin's role in gonorrhea treatment.Annals of medicine and surgery (2012) · 2026Article
- Repurposing epetraborole to combatAntimicrobial agents and chemotherapy · 2026Article
- High in vitro activity of the novel antimicrobial gepotidacin against Neisseria gonorrhoeae isolates in eight WHO Enhanced Gonococcal Antimicrobial Surveillance Programme countries in three WHO regions, 2021-24.The Journal of antimicrobial chemotherapy · 2026Article
- Structural interactions of BWC0977 with Klebsiella pneumoniae topoisomerase IV and biochemical basis of its broad-spectrum activity.Communications biology · 2025Article
- Gepotidacin: First Approval.Drugs · 2025Review
- CommensalAnnual review of microbiology · 2025Review
- Review
28 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: In this phase 2 study, we evaluated the efficacy and safety of oral gepotidacin, a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea. Methods: Adult participants with suspected urogenital gonorrhea were enrolled and completed baseline (day 1) and test-of-cure (days 4-8) visits. Pretreatment and posttreatment urogenital swabs were collected for Neisseria gonorrhoeae (NG) culture and susceptibility testing. Pharyngeal and rectal swab specimens were collected if there were known exposures. Participants were stratified by gender and randomized 1:1 to receive a 1500-mg or 3000-mg single oral dose of gepotidacin. Results: The microbiologically evaluable population consisted of 69 participants, with NG isolated from 69 (100%) urogenital, 2 (3%) pharyngeal, and 3 (4%) rectal specimens. Microbiological eradication of NG was achieved by 97%, 95%, and 96% of participants (lower 1-sided exact 95% confidence interval bound, 85.1%, 84.7%, and 89.1%, respectively) for the 1500-mg, 3000-mg, and combined dose groups, respectively. Microbiological cure was achieved in 66/69 (96%) urogenital infections. All 3 failures were NG isolates that demonstrated the highest observed gepotidacin minimum inhibitory concentration of 1 µg/mL and a common gene mutation. At the pharyngeal and rectal sites, 1/2 and 3/3 NG isolates, respectively, demonstrated microbiological cure. There were no treatment-limiting adverse events for either dose. Conclusions: This study demonstrated that single, oral doses of gepotidacin were ≥95% effective for bacterial eradication of NG in adult participants with uncomplicated urogenital gonorrhea. Clinical Trials Registration: NCT02294682.
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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 OpenQuestion graph.