← Back to all trials
Recruiting
NCT05826990
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
Conditions: Complicated Urinary Tract Infection
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Orchid Pharma Europe GmbH
Location: Fakultní nemocnice Hradec Králové -Ústav klinické biochemie a diagnostiky Hradec Králové
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Participant must be from birth to \10 cells/µL in unspun urine or ≥10 cells/high power field in spun urine.
2. If \5 cells/µL in unspun urine or ≥5 cells/high power field in spun urine.
* Participant demonstrates clinical signs and/or symptoms of either acute pyelonephritis or cUTI at the Screening Visit, as defined by the following criteria:
a. For pyelonephritis, participants must have at least 2 of the following new or worsening signs and/or symptoms: i. If 0 to \
Source: ClinicalTrials.gov (NCT05826990). StuddyBuddy aggregates publicly available trial information.
