A retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant gram-negative bacteria (COMBACTE-MAGNET,WP5)
Bacterial resistance to antimicrobial drugs is a major public health problem. Of greatest concern is the rapid emergence and dissemination of resistance to third generation cephalosporins in Enterobacteriaceae, especially Escherichia coli and Klebsiella pneumoniae. This is frequently seen in association with resistance to other classes of antibiotics leading to a multidrug resistance (MDR) profile. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. In addition, in the last decade there has been an emergence of carbapenemase-producing Enterobacteriaceae, which are also resistant to other antibiotics than carbapenems, leaving few therapeutic options. The overall aim of this study is to provide information about the epidemiology, clinical management and outcome of patients hospitalised with cUTI, including pyelonephritis. To achieve this aim, the investigators will perform a multicentre retrospective observational study in patients with hospitalised cUTI. The study will be conducted in several European countries plus Israel, which have a high prevalence of MDR Gram-negative bacteria (GNB), including Pseudomonas aeruginosa. The study will seek to identify possible modifiable risk factors for treatment failure, especially those related to antibiotic therapy. On completion of this study, the investigators will develop a better understanding of the clinical management of hospitalised patients with cUTI due to MDR GNB in European countries. The investigators will identify the modifiable risk factors for treatment failure. This information will be used to inform better clinical and antibiotic management of cUTI to improve patient outcomes. The study will also be used in the development of hypothesis for future randomised controlled trials in cUTI with new antibiotics. Dissemination of results will take place through peer-reviewed publications and conference presentations.
Study Type
OBSERVATIONAL
Enrollment
1,028
Emergency Hospital Pirogov
Sofia, Bulgaria
University Hospital Queen Joanna
Treatment Failure
Treatment failure will be assessed as number of participants with evidence of treatment failure or mortality within 30 days from initial cUTI diagnosis
Time frame: 30 days
Time to clinical response
Time to clinical response (in days), since initiation of antibiotic treatment
Time frame: 30 days
Time to urological intervention for source control
Time to urological intervention for source control (in days) since initial cUTI diagnosis
Time frame: 30 days
Time to death
Time to death (in days) since original cUTI diagnosis
Time frame: 30 days
Duration of antibiotic therapy
Duration of antibiotic therapy (in days)
Time frame: 30 days
Length of hospital stay
Length of hospital stay (in days)
Time frame: 30 days
Hospital mortality
Hospital mortality during admission
Time frame: 30 days
All cause mortality within 30 days of the original cUTI diagnosis
All cause mortality within 30 days of the original cUTI diagnosis
Time frame: 30 days
All cause of mortality for two months after hospital discharge
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Sofia, Bulgaria
Attikon University Hospital
Athens, Greece
Hippokration Hospital
Thessaloniki, Greece
Kenezy University Hospital
Debrecen, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK)
Nyíregyháza, Hungary
Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet
Sopron, Hungary
Rambam Health Care Campus
Haifa, Israel
Beilinson Hospital, Rabin Medical Center
Petah Tikva, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
...and 11 more locations
All cause of mortality for two months after hospital discharge
Time frame: 60 days
Cost per case of cUTI
Cost per case of cUTI
Time frame: 30 days
Readmissions to the hospital within 60 days of hospital discharge
Readmissions to the hospital within 60 days of hospital discharge
Time frame: 60 days
Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection
Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection
Time frame: 30 days