NCT04167228

Impact of Ceftazidime / Avibactam Treatment vs Better Available Therapy on Mortality of Patients With Infections Caused by Carbapenem-resistant Enterobacteria

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 348 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with infections caused by carbapenem-resistant enterobacteria treated with CAZ-AVI versus patients treated with BAT are compared. The BAT group includes fosfomycin, tigecycline, gentamicin, meropenem and colistin.

Detailed description

Carbapenem-resistant enterobacteria (CRE) are a public health problem. The morbidity and mortality of patients with invasive infections due to CRE are high. The best treatment is unknown, however, combination therapy with at least 2 active drugs is often recommended for high-risk patients, and monotherapy is probably not inferior to this in low-risk patients. Ceftazidime-avibactam is active against many CRE, and in some countries it has been prescribed under compassionate use programs for these infections; It has recently been approved by the FDA and the EMA for specific indications. Recent data suggest that ceftazidime-avibactam may be superior for the treatment of infections caused by sensitive CRE, rather than traditional regimens that often include colistin, usually combined with other drugs. However, these studies include a low number of patients and are subject to important biases. Additionally, the development of resistance to this drug during / after treatment has been described and is worrying.

Conditions

• Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

Type	Name	Description
DRUG	Ceftazidime-Avibactam	Patients with complicated urinary tract infections, nosocomial pneumonia (including pneumonia associated with ventilation), complicated intra-abdominal infections or bacteremia (if the focus of infection is any of the above, the patient should be included in both groups) due to CRE, treated \> 2 days with ceftazidime-avibactam.
DRUG	Best Available Therapy	Patients with complicated urinary tract infections, nosocomial pneumonia (including pneumonia associated with ventilation), complicated intra-abdominal infections or bacteremia (if the focus of infection is any of the above, the patient should be included in both groups) due to CRE, treated \> 2 days with the best available treatment other than ceftazidime-avibactam.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-07-15
• Completion: 2021-05-05
• First posted: 2019-11-18
• Last updated: 2021-07-20

Locations

17 sites across 1 country: Spain