NCT04785924

Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections

A Study Comparing Prospective Use of Imipenem/Cilastatin/Relebactam (IMI/REL) to Retrospective Data Using Meropenem/ Vabobactam (MVB) and Ceftazidime/Avibactam (CZA) in Treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae Infections

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae infections at a tertiary care hospital. The objectives of the study are to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.

Conditions

• Carbapenem-Resistant Enterobacteriaceae Infection
• KPC
• Gram-Negative Bacterial Infections
• Antibiotic Resistant Infection

Interventions

Type	Name	Description
DRUG	Imipenem+Relebactam	Antibiotic treatment for KPC producing CRE-containing gram-negative infections

Timeline

• Start date: 2021-06-07
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2021-03-08
• Last updated: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study