Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3
Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.The trials are registered at Clinicaltrials.gov (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).
Authors
- Caroline Perry (ORCID: https://orcid.org/0000-0001-6387-319X)
- Keith S. Kaye (ORCID: https://orcid.org/0000-0003-2051-1732)
- Matthew Helgeson
- Amanda Sheets (ORCID: https://orcid.org/0000-0003-3115-5016)
- Emily Jarvis (ORCID: https://orcid.org/0000-0001-7187-6382)
- Florian Wagenlehner (ORCID: https://orcid.org/0000-0002-2909-0797)
- Salim Janmohamed
- Jeremy Dennison (ORCID: https://orcid.org/0000-0002-0063-0614)
- David A. Talan (ORCID: https://orcid.org/0000-0002-7048-8086)
- Nicole E. Scangarella-Oman (ORCID: https://orcid.org/0000-0003-4211-8261)
Institutions
- Rutgers, The State University of New Jersey (US)
- University of California, Los Angeles (US)
- Justus-Liebig-Universität Gießen (DE)
- Age UK (GB)
- Johnson University (US)
- South College (US)
- Centre for Inflammation Research (GB)
Publication Details
- Journal
- Contemporary Clinical Trials Communications
- Published
- 2025-11-20
- DOI
- https://doi.org/10.1016/j.conctc.2025.101572
- Primary Topic
- Urinary Tract Infections Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00