MedTrace Logo

Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections

NCT05258851 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-06-14

No results posted yet for this study

Summary

Carbapenem-Resistant Enterobacteriaceae (CRE) infections are a growing national and international challenge in healthcare settings. This is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with CRE reaching up to 50% as per the Centers of Disease Control and Prevention.

Colistin-based combination regimens have been the mainstay for treating CRE-related infections. Ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against CRE along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. However, randomized clinical trials are lacking.

This non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with CRE infections in comparison to colistin-based regimens.

Conditions

  • Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

DRUG

Ceftazidime-avibactam

Experimental

DRUG

Colistin

Control

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Zainab Al Duhailib · King Faisal Specialist Hospital & Research Center

  • Hakeam Hakeam · King Faisal Specialist Hospital & Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-04-12
Completion
2024-01-28

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05258851 on ClinicalTrials.gov