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NCT02714595 · ClinicalTrials.gov registry record · Phase 3
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
A Phase 3 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
NCT02714595: Completed Phase 3 study, sponsored by Shionogi.
NCT02714595 is a Phase 3 study that has completed, run by Shionogi. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02714595, a Phase 3 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
Study Summary
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
Primary Outcome
Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: C
Interventions
- DRUG Cefiderocol
- DRUG Best Available Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2016-09-07 |
| Est. Completion | 2019-04-22 |
| Phase | Phase 3 |
What the finished NCT02714595 record still lists
NCT02714595 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Cefiderocol is the first listed.
NCT02714595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02714595 about?
NCT02714595 is a clinical study titled "Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens". This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
What is the current status of trial NCT02714595?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2016-09-07. Estimated completion is 2019-04-22.
What interventions are being tested in trial NCT02714595?
The interventions under investigation include: Cefiderocol (DRUG), Best Available Therapy (DRUG).
Who is sponsoring clinical trial NCT02714595?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02714595's enrollment target sits among peer trials
152 1513th of 2000 higher than 484 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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