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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRE infected patients treated with ceftazidime-avibactam | Patients with infections caused by carbapenem resistant enterobacteria treated 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological response | Microbiological response in the Test-of-cure, categorized as eradication, microbiological failure or uncertain. | 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 |
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Inclusion Criteria:
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:
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Patients with infections caused by carbapenem resistant enterobacteria
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| Name | Affiliation | Role |
|---|---|---|
| Juan José Castón Osorio, MD | Hospital General Universitario Reina Sofía de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Hospital Universitario de Gran Canaria "Dr. Negrín" |
The information collected will be of public access by request.
After the trial results are public.
By request to uicec@imibic.org
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|
| 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. |
|
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. |
| 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 | 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. | 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 | At day 30 after the start of the treatment |
| Recurrence | Reappearance of the infection according to the same criteria and by the same microorganism | At day 30 after the start of the treatment |
| Safety evaluation of the treatment | Number of adverse reactions related to therapy | At day 30 after the start of the treatment |
| Las Palmas de Gran Canaria |
| Canary Islands |
| 35019 |
| Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | Coruña | 15006 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Pontevedra | 36211 | Spain |
| Hospital Universitario Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital Clínico de Barcelona | Barcelona | 08036 | Spain |
| Hospital San Pedro de Alcántara | Cáceres | 10003 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
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