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NCT06086626 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
A Phase 2 study of Gram-negative Bacterial Infections, sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT06086626 is a Phase 2 study of Gram-negative Bacterial Infections that has completed, run by Shionogi. The registered enrollment target is 30 participants, below the 435-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT06086626, a Phase 2 study of Gram-negative Bacterial Infections, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG Cefiderocol
Study Locations (4)
Arkansas
- Arkansas Children's Hospital - Little Rock
North Carolina
- Duke University - Durham
Western Cape
- Tygerberg Hospital - Cape Town
Other
- Chang Gung Memorial Hospital, Linkou Department of Pediatrics - Taoyuan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06086626
The ClinicalTrials.gov registry entry for NCT06086626 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 435-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (93% lower). The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gram-negative Bacterial Infections appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT06086626 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Arkansas, North Carolina, Western Cape.
Frequently Asked Questions
What is clinical trial NCT06086626 about?
NCT06086626 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants". The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.
What is the current status of trial NCT06086626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-03-14. Estimated completion is 2025-03-31.
What conditions does trial NCT06086626 study?
This clinical trial studies the following conditions: Gram-negative Bacterial Infections.
What interventions are being tested in trial NCT06086626?
The interventions under investigation include: Standard of Care (DRUG), Cefiderocol (DRUG).
Who is sponsoring clinical trial NCT06086626?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06086626 being conducted?
This trial has 4 study locations across Arkansas, North Carolina, Western Cape. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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