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NCT04010539 (Gepotidacin Ceftriaxone Azithromycin in Urinary Tract Infections): BVCT ex-ante prediction vs. reported outcome

On 15 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 26 Feb 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (non-inferiority is sufficient given the high efficacy of antibiotics and high rate of resistance)..

Clinical Trial

NCTID
NCT04010539
Acronym
EAGLE-1
Drug Name
Gepotidacin Ceftriaxone Azithromycin
Drug MoA
oral inhibitor of bacterial DNA gyrase and topoisomerase IV
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Urinary Tract Infections
Human Patients
628
Sponsor
GSK
Phase
Phase 3

Prediction of , index 1466

Prospective Prediction
Prediction Index
1466
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
11 days in advance
Readout Data Interpretation
primary endpoint of non-inferiority to SoC met.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (non-inferiority is sufficient given the high efficacy of antibiotics and high rate of resistance).
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
Phase
Phase 3
Status
Completed
Enrollment
628
Lead sponsor
GlaxoSmithKline
Conditions
Gonorrhea
Interventions
DRUG: Gepotidacin; DRUG: Ceftriaxone; DRUG: Azithromycin
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2019-10-21
Primary completion
2023-10-10
Completion
2023-10-10
Results first posted
2024-05-30
Primary outcomes
  • Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) (Baseline (Day 1) and TOC visit (Day 4 to 8))

NCT04010539 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials