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

NCT ID: NCT04167228

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 348 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-05-05

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CRE infected patients treated with ceftazidime-avibactam

Patients with infections caused by carbapenem resistant enterobacteria treated with ceftazidime-avibactam

Ceftazidime-Avibactam

Intervention Type: DRUG

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.

CRE infected patients treated with best available treatment

Patients with infections caused by carbapenem resistant enterobacteria treated with the best available treatment

Best Available Therapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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. Patients with bacteremia can be included in one of the other cohorts if the focus of the infection is the urinary tract, respiratory tract or an intra-abdominal infection and they meet the appropriate criteria (see below). The retrospective design of this study has been carried out to avoid the induction of the prescription of ceftazidime-avibactam in each center. For this, patients will be included at the end of the period of evaluation of the primary objective (crude mortality at day 30). If more than one patient can be used as a control, the one with the closest admission date will be chosen.

Control: local historical cohort - Patients treated with ceftazidime-avibactam will be compared with patients treated with BAT. Because after approval of the use of ceftazidime-avibactam, BAT could be used less frequently to treat this type of infection, patients treated with BAT from January 1, 2014 will be included. These patients will be matched by hospital, type of hospital. infection (urinary tract vs others) and INCREMENT score.

Exclusion Criteria

• The infection is considered polymicrobial according to the standard microbiological interpretation of the crop results (except for complicated intra-abdominal infections, in which case, polymicrobial infections are allowed).
• Patients with infections caused by CRE without susceptibility to ceftazidime-avibactam.
• The patient is participating in a clinical trial that involves active treatment for infections.
• Patients with cardiopulmonary no resuscitation order or with a life expectancy < 30 days.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan José Castón Osorio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Locations

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Gran Canaria "Dr. Negrín"

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, Coruña, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario Vall d'Hebrón

Barcelona, , Spain

Hospital Clínico de Barcelona

Barcelona, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

FCO-CAV-2018-01

Identifier Type: -

Identifier Source: org_study_id