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

NCT05826990 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-12

No results posted yet for this study

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.

Conditions

  • Complicated Urinary Tract Infection

Interventions

DRUG

cefepime and enmetazobactam combination

Cefepime and enmetazobactam fixed dose combination administered intravenously every 8 hours as single drug formulation

Sponsors & Collaborators

  • Linical Co., Ltd.

    collaborator INDUSTRY

  • Allecra

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2025-09-30
Completion
2026-03-30
FDA Drug
Yes

Countries

  • Czechia
  • France
  • Hungary
  • Poland
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826990 on ClinicalTrials.gov