Back to resultsExpanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Primary Purpose
Bacterial Infections
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Cefiderocol
Sponsored by
About this trial
This is an expanded access trial for Bacterial Infections focused on measuring S-649266, cefiderocol, Gram-negative
Eligibility Criteria
Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03780140
Brief Title
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Official Title
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
S-649266, cefiderocol, Gram-negative
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cefiderocol
Other Intervention Name(s)
S-649266
Intervention Description
Cefiderocol for intravenous infusion
10. Eligibility
Sex
All
Eligibility Criteria
Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shionogi Clinical Trials Administrator Clinical Support Help Line
Organizational Affiliation
Shionogi
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://www.shionogi.com/research/compassionate-use/
Description
Shionogi Compassionate Use
Learn more about this trial
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
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