A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
Completed · Phase 2 · NCT04215991
Conditions: Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
At a glance
- Research payments reported, 2025
- $6,315
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 91
About the trial
- Sponsor
- Shionogi
- Tested
- Cefiderocol (drug), Standard of Care (drug)
- Dates
- Started 2020-02-19; completion 2024-09-17
- Results posted
- Not yet
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to \< 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
From ClinicalTrials.gov, last updated 2025-05-25. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Shionogi Inc reported $6,315 in research payments for this study in 2025 (3 payments).
Products named: Fetroja
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.