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Clinical trial

A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

NCT04335539 is registered in ClinicalTrials.gov with Shionogi as lead sponsor.

NCT NCT04335539
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Registry record

As filed in ClinicalTrials.gov.

Title
A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections
Lead sponsor
Shionogi
Phase
Phase 2
Overall status
Completed
Start date
August 21, 2020
Completion date
February 6, 2023
Enrollment
53 (actual)
Sites
23

Conditions

As the registry lists them; a condition with its own page is linked.

bloodstream infections (bsi), complicated intra-abdominal infection (ciai), complicated urinary tract infection (cuti), gram-negative bacterial infections, hospital acquired pneumonia (hap), sepsis, ventilator-acquired pneumonia