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

Maimónides Biomedical Research Institute of Córdoba348 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

348

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

Ceftazidime-AvibactamDRUG

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.

Best Available TherapyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

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

Outcomes

Primary Outcomes

30-day mortality rate

To describe the 30-day mortality rate in the caz-avi group and in the group with the best available therapy of patients with infections caused by carbapenem-resistant enterobacteria.

Time frame: At day 30 after the start of the treatment

Clinical response on day 21

To describe the clinical response on day 21 of the caz-avi group and in the group with the best available therapy of patients with infections caused by carbapenem-resistant enterobacteria.

Time frame: At day 21 after the start of the treatment

Secondary Outcomes

Microbiological response

Microbiological response in the Test-of-cure, categorized as eradication, microbiological failure or uncertain.

Time frame: At day 30 after the start of the treatment

30-day mortality rate in the group of patients with caz-avi in monotherapy and in the group with combined therapy with caz-avi

Describe the 30-day mortality rate in the group of patients with caz-avi in monotherapy and in the group with combined therapy with caz-avi, who present with infections caused by carbapenem-resistant enterobacteria.

Time frame: At day 30 after the start of the treatment

Risk factors associated with the development of resistance to ceftazidime-avibactam during treatmen

Describe the rates and risk factors associated with the development of resistance to ceftazidime-avibactam (MIC\> 8 microg / mL) during treatment

Time frame: At day 30 after the start of the treatment

Duration of hospital stay after infection

Number of days elapsed from the end of antibiotic treatment until discharge and duration of ICU stay if appropriate.

Data from ClinicalTrials.gov

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