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

NCT04167228 | Completed

• 1 other identifier: FCO-CAV-2018-01
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 17

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.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Keywords

ceftazidime / avibactam; carbapenem resistant enterobacteria

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At day 21 after the start of the treatment

Secondary Outcomes (7)

• Microbiological response

  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

  At day 30 after the start of the treatment

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

  At day 30 after the start of the treatment

• Duration of hospital stay after infection

  At day 30 after the start of the treatment

• Duration of antibiotic treatment during the episode

  At day 30 after the start of the treatment

Study Arms (2)

CRE infected patients treated with ceftazidime-avibactam

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

Drug: Ceftazidime-Avibactam

CRE infected patients treated with best available treatment

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

Drug: Best Available Therapy

Interventions

Ceftazidime-Avibactam 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 ceftazidime-avibactam

Best Available Therapy 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.

CRE infected patients treated with best available treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with infections caused by carbapenem resistant enterobacteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (17)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario de Gran Canaria "Dr. Negrín"

Las Palmas de Gran Canaria, Canary Islands, 35019, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Coruña, 15006, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36211, Spain

Location

Hospital Universitario Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clínico de Barcelona

Barcelona, 08036, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Interventions

avibactam, ceftazidime drug combination

Study Officials

• Juan José Castón Osorio, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: October 1, 2019
• Primary Completion: July 15, 2020
• Study Completion: May 5, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the trial results are public.
• Access Criteria: By request to uicec@imibic.org

Locations

ES (17)