Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03583333
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2018-06-28
Brief Title:
ImipenemCilastatinRelebactam MK-7655A Versus PiperacillinTazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia MK-7655A-016
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multi-national Phase 3 Randomized Double-Blind Active Comparator-Controlled Clinical Trial to Study the Safety Tolerability and Efficacy of ImipenemCilastatinRelebactam MK-7655A Versus PiperacillinTazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the efficacy and safety of a FDC of imipenemcilastatin IMI and relebactam REL IMIREL MK-7655A compared to piperacillintazobactam PIPTAZ in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia HABP or Ventilator-Associated Bacterial Pneumonia VABP The primary hypothesis is that IMIREL is non-inferior to PIPTAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-7655A-016 | OTHER | None | None |
| PHRR190814-002177 | REGISTRY | None | None |
| 2018-003202-82 | EUDRACT_NUMBER | PHRR | None |