A multicenter, single-arm, open-label study to assess the pharmacokinetics, safety, and tolerability of cefiderocol in hospitalized pediatric patients from birth to < 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503757-35-00

Acronym

1904R2136

Enrollment

Registered

2023-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aerobic Gram-negative bacterial infections

Brief summary

Cmax, AUC0-inf, and t1/2 after single dose, Cmax, AUC0-τ, and t1/2 after a minimum of 4 doses of cefiderocol

Detailed description

Adverse events, Vital signs, Physical examinations, Clinical laboratory assessments, Death

Interventions

DRUGFetcroja 1 g powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Cmax, AUC0-inf, and t1/2 after single dose, Cmax, AUC0-τ, and t1/2 after a minimum of 4 doses of cefiderocol	—

Secondary

Measure	Time frame
Adverse events, Vital signs, Physical examinations, Clinical laboratory assessments, Death	—

Countries

Bulgaria, Greece, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026