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NCT05204563 · ClinicalTrials.gov registry record · Phase 3
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
A Phase 3 study, sponsored by Evopoint Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
NCT05204563: Completed Phase 3 study, sponsored by Evopoint Biosciences.
NCT05204563 is a Phase 3 study that has completed, run by Evopoint Biosciences. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05204563, a Phase 3 study, has completed, sponsored by Evopoint Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
Study Summary
This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality.
Primary Outcome
The all-cause mortality rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14.
Interventions
- DRUG Imipenem/Cilastatin/Relebactam
- DRUG Combination of Imipenem/Cilastatin and XNW4107
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-07-31 |
| Est. Completion | 2024-09-29 |
| Phase | Phase 3 |
What the finished NCT05204563 record still lists
NCT05204563 is an interventional study that assigns participants to a tested intervention. The registered 450 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 (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Imipenem/Cilastatin/Relebactam is the first listed.
NCT05204563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05204563 about?
NCT05204563 is a clinical study titled "Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)". This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferi...
What is the current status of trial NCT05204563?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2022-07-31. Estimated completion is 2024-09-29.
What interventions are being tested in trial NCT05204563?
The interventions under investigation include: Imipenem/Cilastatin/Relebactam (DRUG), Combination of Imipenem/Cilastatin and XNW4107 (DRUG).
Who is sponsoring clinical trial NCT05204563?
This trial is sponsored by Evopoint Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05204563's enrollment target sits among peer trials
450 837th of 2000 higher than 1,137 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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