NCT03780140|Unknown
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
1 other identifier
S-649266-EA
Study Type
expanded_access
Target
N/A
Locations
0 countries
Sites
N/A
Timeline
RegisteredDec 2018
Brief Summary
Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2018
Completed2 days until next milestone
First Posted
Study publicly available on registry
December 19, 2018
CompletedLast Updated
February 28, 2020
Status Verified
February 1, 2020
First QC Date
December 17, 2018
Last Update Submit
February 25, 2020
Conditions
Keywords
S-649266cefiderocolGram-negative
Interventions
Eligibility Criteria
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Shionogilead
Related Links
MeSH Terms
Conditions
Bacterial Infections
Interventions
Cefiderocol
Condition Hierarchy (Ancestors)
Bacterial Infections and MycosesInfections
Intervention Hierarchy (Ancestors)
Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds
Study Officials
- STUDY DIRECTOR
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogi
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2018
First Posted
December 19, 2018
Last Updated
February 28, 2020
Record last verified: 2020-02