Heterogeneity of Recent Phase 3 Complicated Urinary Tract Infection Clinical Trials.
Simon PortsmouthAlmasa BassRoger EcholsGlenn S TillotsonPublished in: Open forum infectious diseases (2021)
A study design can follow regulatory guidelines but still have variable populations. The proportion of AP within a study varied greatly and influenced population demographics (age, gender) and baseline microbiology. A smaller proportion of AP resulted in an older patient population, fewer females, less E coli, and lower proportions of patients achieving success. Fluoroquinolones and piperacillin/tazobactam should be reconsidered as active comparators given the high rates of resistance to these antibiotics.
Keyphrases
- urinary tract infection
- clinical trial
- transcription factor
- end stage renal disease
- newly diagnosed
- ejection fraction
- chronic kidney disease
- escherichia coli
- peritoneal dialysis
- physical activity
- mental health
- randomized controlled trial
- single cell
- case report
- clinical practice
- patient reported outcomes
- gram negative
- phase ii