MedTrace Logo

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

NCT04785924 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-09-04

No results posted yet for this study

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

DRUG

Imipenem+Relebactam

Antibiotic treatment for KPC producing CRE-containing gram-negative infections

Sponsors & Collaborators

Principal Investigators

  • Christopher Polk, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2023-01-12
Completion
2023-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785924 on ClinicalTrials.gov