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Clinical trial

An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

NCT04215991 is registered in ClinicalTrials.gov with Shionogi as lead sponsor.

NCT NCT04215991
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age
Lead sponsor
Shionogi
Phase
Phase 2
Overall status
Completed
Start date
February 19, 2020
Completion date
September 17, 2024
Enrollment
91 (actual)
Sites
25

Conditions

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

complicated urinary tract infection (cuti), gram-negative bacterial infections, hospital acquired bacterial pneumonia (habp), ventilator associated bacterial pneumonia (vabp)