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RESCUING
Current status: Completed
combacte-magnet

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.

Elaborate insights

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.

Study information

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

  • Christiane Vank

    Clinical Trial Manager / EFPIA / AiCuris Anti-infective Cures GmbH

  • Cuong Vuong

    Principal Scientist / EFPIA / AiCuris Anti-infective Cures GmbH

  • Evelyn Shaw Perujo

    Research physician / Academic / Hospital Universitari de Bellvitge

Study level information

General information
  • Study NO NCT02641015
  • Study Name RESCUING
  • Study Type Database Analysis
  • Study Status Report Complete
  • Enrollment Period N/A - 03/16
Enrollment
  • Total subjects planned 1000
  • Total subjects screened 0
  • Total subjects enrolled 1013
  • Total subjects completed 1009

Study timeline

Light blue
Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 2
Sites activated 2
Bulgaris
Subjects
planned
80
Subjects
enrolled
103
Subjects
completed
103
Subjects completed
0.0%
Sites planned 2
Sites activated 2
Greece
Subjects
planned
80
Subjects
enrolled
89
Subjects
completed
88
Subjects completed
0.0%
Sites planned 3
Sites activated 3
Hungary
Subjects
planned
120
Subjects
enrolled
107
Subjects
completed
107
Subjects completed
0.0%
Sites planned 3
Sites activated 3
Subjects
planned
120
Subjects
enrolled
185
Subjects
completed
185
Subjects completed
0.0%
Sites planned 3
Sites activated 3
Italy
Subjects
planned
120
Subjects
enrolled
125
Subjects
completed
125
Subjects completed
0.0%
Sites planned 2
Sites activated 2
Romania
Subjects
planned
120
Subjects
enrolled
142
Subjects
completed
140
Subjects completed
0.0%
Sites planned 3
Sites activated 3
Spain
Subjects
planned
120
Subjects
enrolled
162
Subjects
completed
161
Subjects completed
0.0%
Sites planned 2
Sites activated 2
Turkey
Subjects
planned
80
Subjects
enrolled
100
Subjects
completed
100
Subjects completed
0.0%