An observational study in Carbapenem-Resistant Enterobacteriaceae Infection, sponsored by Maimónides Biomedical Research Institute of Córdoba. Completed at 17 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 348 is above the median of 240 across 2,136 observational studies indexed under Infections.
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Patients with infections caused by carbapenem resistant enterobacteria
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:
Patients with infections caused by carbapenem resistant enterobacteria treated with ceftazidime-avibactam
Drug: Ceftazidime-Avibactam
Patients with infections caused by carbapenem resistant enterobacteria treated with the best available treatment
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 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 the best available treatment other than ceftazidime-avibactam.
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
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.
Time frame: At day 30 after the start of the treatment
Duration of antibiotic treatment during the episode
Number of days of antibiotic treatment during the episode
Time frame: At day 30 after the start of the treatment
Recurrence
Reappearance of the infection according to the same criteria and by the same microorganism
Time frame: At day 30 after the start of the treatment
Safety evaluation of the treatment
Number of adverse reactions related to therapy
Time frame: At day 30 after the start of the treatment
Plan to share: Yes — The information collected will be of public access by request.
Supporting information: Study protocol, Sap, Csr
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Maimónides Biomedical Research Institute of Córdoba