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
This study is performed in collaboration with AiCuris.
The study’s outcomes will help identify the optimal treatments and clinical management procedures. They will also help identify the patient categories and clinical centers that can be used to optimize future Phase II / Phase III clinical trials of novel candidate drugs.
The study will provide detailed insights into such things as:
- demographical and clinical characteristics of ICU-patients who develop cUTI;
- risk factors associated with developing cUTI;
- current clinical management of patients with complicated urinary tract infections;
- risk factors associated with early treatment failures;
- duration of patients’ hospital stays and antibiotic therapies;
- mortality rates;
- costs involved in the clinical management of multidrug-resistance problems.
The RESCUING project is gathering observational data about the treatment of some 1000 patients with complicated urinary tract infections. Data will be collected retrospectively from some 40 consecutive patients in 25 medical centers. These are located in eight countries where the prevalence of multidrug-resistant Gram-negative bacteria is seen to be high. That includes Bulgaria, Greece, Hungary, Israel, Italy, Romania, Turkey and Spain.
Each patient record in the study contains information about demographics, comorbidities, functional capacity, place of infection and predisposing risk factors. It also contains clinical data, clinical pathology data, microbiological data, imaging test data, data on infection management, antibiotic therapy and clinical outcomes. As well as details of discharge and, if applicable, of readmission and/or death. All patients will be followed up for up to two months after their discharge from the hospital.
Study team members
Clinical Trial Manager / EFPIA / AiCuris Anti-infective Cures GmbH
Principal Scientist / EFPIA / AiCuris Anti-infective Cures GmbH
Evelyn Shaw Perujo
Research physician / Academic / Hospital Universitari de Bellvitge
Study level information
- Study NO NCT02641015
- Study Name RESCUING
- Study Type Database Analysis
- Study Status Report Complete
- Enrollment Period N/A - 03/16
- Total subjects planned 1000
- Total subjects screened 0
- Total subjects enrolled 1013
- Total subjects completed 1009
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- Preparation phase
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- Trial period
Country level information