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.
Participant must be from birth to <18 years of age. Participants up to 2 months must have been born at term or preterm with a gestational age ≥32 weeks.
Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from participant (if age appropriate according to local regulations).
Participant has a negative urine and/or serum human chorionic gonadotropin test at screening visit. As serum tests may miss an early pregnancy, relevant menstrual history, and sexual history, including methods of contraception, should be considered
Participant agrees to avoid conception from the time of screening until 7 days after receipt of study intervention and agrees not to attempt pregnancy from the time of screening until 7 days after EOT with study intervention, and participant agrees to follow guidelines received regarding continuation of abstinence, initiation of abstinence or about allowed contraception, and
History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to cefepime, any cephalosporin, penicillins, β-lactamase inhibitors (e.g., tazobactam, sulbactam, or clavulanic acid), or other β-lactam agents.
Previous enrolment in this study, or in another interventional study ≤30 days before i.v. administration of study intervention.
Concurrent infection requiring systemic antibiotics in addition to the i.v. study intervention therapy at the time of first study intervention administration.
Receipt up to 24 hours of short-acting antibacterial agent with a daily dose not completed. (Refer protocol ► Section 10.5, Appendix 5 for the list of allowed and disallowed antibiotics).
Single group
cefepime and enmetazobactam combination
DrugCefepime and enmetazobactam fixed dose combination administered intravenously every 8 hours as single drug formulation
Pharmacokinetics Cmax
Maximum Plasma Concentration \[Cmax\] ; unit= mg/L
Pharmacokinetics Tmax
Time to reach Cmax (Tmax) ; unit= h
Pharmacokinetics AUC0-tau
Area under the plasma concentration time curve from time zero to the end of the dosing interval (AUC0-tau) ; unit= mg.h/L
Pharmacokinetics AUC0-inf
Area under the concentration time curve from time zero extrapolated to infinity (AUC0-inf) ; unit= mg.h/L
Efficacy assessment
Efficacy Overall success rate (Combined clinical and microbiological success rate) * Clinical response * Microbiological response The main efficacy endpoint is the overall success rate (Combined clinical and microbiological success) in the m-MITT population at TOC. The other efficacy endpoints are listed below: * Clinical response of cure at TOC in m-MITT population * Microbiological response of eradication at TOC in m-MITT population * Overall success rate at Day 3, end-of-therapy (EOT), LFU in m-MITT population * Clinical response rate at the Day 3, EOT, LFU visits in m-MITT population * Microbiological response rate at the Day 3, EOT, LFU visits in m-MITT population * Overall success rate at Day 3, EOT, TOC, LFU in Clinically Evaluable (CE) and in microbiologically evaluable (ME) populations * Clinical response rate at Day 3, EOT, TOC, LFU in CE and ME populations * Microbiological response at the Day 3, EOT, LFU visits in CE and ME populations
Click on the lead sponsor to view all of their trials.
Orchid Pharma Europe GmbH
Lead sponsor
Innvocept Global Solutions Private Limited
Collaborator
