Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02641015
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2015-12-23
Brief Title:
Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI RESCUING
Sponsor:
Institut dInvestigació Biomèdica de Bellvitge
Organization:
Institut dInvestigació Biomèdica de Bellvitge
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESCUING
Brief Summary:
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-MAGNETWP5
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None