Clinical Trials Logo
  1. Home
  2. Bacterial Pneumonia
  3. NCT02493764

Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) — RESTORE-IMI 2  

Bacterial Pneumonia Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

Clinical Trial Summary

This study aims to compare treatment with a fixed-dose combination (FDC) of imipenem/relebactam/cilastatin (IMI/REL) with a FDC of piperacillin/tazobactam (PIP/TAZ) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02493764
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date November 24, 2015
Completion date April 3, 2019
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01570192 - Clinical Trials to Reduce the Risk of Antimicrobial Resistance Phase 2
Recruiting NCT04952337 - Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)
Completed NCT02531438 - Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13) Phase 3
Completed NCT00079885 - Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia Phase 3
Recruiting NCT05629741 - A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101 Phase 1
Completed NCT05417997 - Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients Phase 3
Withdrawn NCT00645619 - Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children
Completed NCT00509106 - Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia Phase 3
Completed NCT00080496 - Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia Phase 3
Completed NCT03158727 - Cx611-0204 SEPCELL Study Phase 1/Phase 2
Completed NCT00621504 - Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia Phase 3
Completed NCT00124020 - Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus Phase 3
Completed NCT00081575 - Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia Phase 3
Completed NCT00451386 - Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036) Phase 2
Recruiting NCT03752320 - Multiplex Polymerase Chain Reaction in Postoperative Pneumonia After Thoracic Surgery
Active, not recruiting NCT04779242 - Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia Phase 3
Completed NCT00763620 - Assessment of the Diagnostic Capacity of the Mini-broncho Alveolar Lavage Performed Through a Suction Catheter N/A
Completed NCT00107952 - Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus Phase 3
Terminated NCT03862040 - Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia Phase 1
Recruiting NCT05531149 - Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia Phase 3