Trial intelligence / Profile preview

Cefiderocol in Paediatric Gram-negative Bacterial Infections

NCT04335539Phase 2

Key facts

Status: Completed
Start: Aug 2020
Primary completion: Feb 2023
Countries: 9
Sponsor: Shionogi & Co., Ltd.
Modality: Small Molecules

Drugs: cefiderocol
Conditions: Gram-negative bacterial infectionbloodstream infection (BSI)Intra-abdominal infection (IAI)hospital-acquired pneumonia (HAP)ventilator-associated pneumonia (VAP)

Overview

Phase 2, open-label trial of cefiderocol in Gram-negative bacterial infection, bloodstream infection (BSI), Intra-abdominal infection (IAI) and 4 more, sponsored by Shionogi & Co., Ltd. Primary endpoints: Number of Participants With Treatment-Emergent Adverse Events (Single Dose Phase), Number of Participants With Treatment-Emergent Adverse Events (Multiple Dose Phase) and 6 more. Started Aug 2020; status: completed.

Design

Study design: Non-randomizedOpen-labelSingle group

Who it enrols

Hospitalized paediatric participants (3 months to <18 years) with suspected or confirmed aerobic Gram-negative bacterial infections requiring IV antibiotics.

Endpoints

Primary

Number of Participants With Treatment-Emergent Adverse Events (Single Dose Phase)Day 1 to Day 28
Number of Participants With Treatment-Emergent Adverse Events (Multiple Dose Phase)Day 1 to Day 42
Maximum Observed Plasma Concentration of Cefiderocol (Single Dose Phase)8 hours
Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to Infinity of Cefiderocol (Single Dose Phase)8 hours
Apparent Terminal Elimination Half-life of Cefiderocol (Single Dose Phase)8 hours

Secondary

Number of Participants With a Clinical OutcomeDay 42
Number of Participants With a Microbiological OutcomeDay 42

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