This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pharmacokinetics Cmax
Timeframe: Day 1 - Day 2
Pharmacokinetics Tmax
Timeframe: Day 1 - Day 2
Pharmacokinetics AUC0-tau
Timeframe: Day 1 - Day 2
Pharmacokinetics AUC0-inf
Timeframe: Day 1 - Day 2
Pharmacokinetics t1/2
Timeframe: Day 1 - Day 2
Pharmacokinetics CL & Vd
Timeframe: Day 1 - Day 2
Pharmacokinetics Cmin
Timeframe: Day 1 - Day 2
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)