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NCT03032380 · ClinicalTrials.gov registry record · Phase 3
Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
A Phase 3 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT03032380: Completed Phase 3 study, sponsored by Shionogi.
NCT03032380 is a Phase 3 study that has completed, run by Shionogi. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03032380, a Phase 3 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.
Primary Outcome
The all-cause mortality (ACM) rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from the first infusion of study drug up to Day 14. The Modified Intent-to-Treat Population included all randomized participants who met either of the following criteria: * Evidence of Gram-negative infection of the lower respiratory tract based on a culture, Gram-stain, or other diagnostic test * Evidence of a lower respirato
Interventions
- DRUG Cefiderocol
- DRUG Meropenem
- DRUG Linezolid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2019-04-01 |
| Phase | Phase 3 |
What the finished NCT03032380 record still lists
NCT03032380 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Cefiderocol is the first listed.
NCT03032380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03032380 about?
NCT03032380 is a clinical study titled "Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens". The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-as...
What is the current status of trial NCT03032380?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2017-10-24. Estimated completion is 2019-04-01.
What interventions are being tested in trial NCT03032380?
The interventions under investigation include: Cefiderocol (DRUG), Meropenem (DRUG), Linezolid (DRUG).
Who is sponsoring clinical trial NCT03032380?
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 NCT03032380's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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