NCT05826990

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

Single Group Phase 2 Study to Investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam Administered by IV Over 2 Hr in Male or Female Participants From Birth to Less Than 18 Years of Age Hospitalised With cUTI

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Allecra · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to evaluate the blood concentrations and safety of the fixed dose combination of 2 drugs, cefepime with enmetazobactam administered intravenously in participants aged from birth to less than 18-years of age, hospitalised with a complicated urinary tract infection. The treatment duration will be between 3 and 7 days, depending on the time needed for disappearance of signs and symptoms of the infection. The participant will need to be hospitalised at least during the treatment administration period. After the last administration of cefepime and enmetazobactam, there will be the end of treatment visit (EOT), then 2 follow-up visits at 7 days (Test of Cure (TOC)), then 14 days (Late Follow-up (LFU)) after the end of treatment visit. The End of study Visit (EOS) will be conducted via telephone call (or a visit deemed necessary as per the investigator) 28 days after the EOT visit. The participants may be discharged from hospital at the discretion of the investigator after the end of treatment visit but will be required to return to the hospital for the 2 follow-up visits.

Conditions

• Complicated Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	cefepime and enmetazobactam combination	Cefepime and enmetazobactam fixed dose combination administered intravenously every 8 hours as single drug formulation

Timeline

• Start date: 2023-09-11
• Primary completion: 2025-09-30
• Completion: 2026-03-30
• First posted: 2023-04-24
• Last updated: 2024-01-12

Locations

6 sites across 6 countries: Czechia, France, Hungary, Poland, Slovakia, Spain

Regulatory

• FDA-regulated drug study