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Trial Stories: RESCUING in Retrospect

In this trial series we are diving into COMBACTE trials that have been carried out and (almost) completed with insights from some of the study leads or members. We kick off with RESCUING, a trial that has been completed in 2019.

COMBACTE-MAGNET's RESCUING was a retrospective study that laid the groundwork for improvements in management and treatment of patients with healthcare-associated complicated urinary tract infections (cUTI) with multidrug-resistant (MDR) bacteria, a growing problem in hospitals across Europe. RESCUING started in 2015, and was one of the first COMBACTE-led public-private collaborations with AiCuris, a pharmaceutical company focused on the discovery, research and development of novel, resistance-breaking antiviral and antibacterial agents for the treatment of severe and potentially life-threatening infectious diseases.

Urinary tract infections

Pathogenic bacteria resistant to antibiotics are a major threat to the health of any of us, but no people are more vulnerable to multidrug-resistant pathogens than severely ill patients with other health problems. Many such patients develop urinary tract infections, including hard-to-treat complicated ones. There was a lot to be learned about, for example, current patient populations, treatment successes or failures, or even the burden urinary tract infections have on patients and health care systems in Europe.

To the rescue

RESCUING (REtrospective observational Study to assess the clinical management and outcomes of hospitalized patients with Complicated Urinary tract INfection in countries with a high prevalence of multidrug resistant Gram-negative bacteria) was designed to fill in these gaps. The aim was to provide information about the epidemiology, clinical management and outcomes of patients hospitalized with cUTI, including acute pyelonephritis. The study was set up to give insight into public health questions such as the burden of MDR in high-resistance countries, the medical impact of resistance, and the healthcare costs associated with MDR.

RESCUING’s targeted goal of enrolled patients was reached in 2016. Over 1000 patients were enrolled at 20 sites across 8 countries (Bulgaria, Greece, Hungary, Israel, Italy, Romania, Turkey and Spain).

  • With 1006 patients recruited, we had a large body of data on treatment failures in a variety of patients with cUTI, enough to carry out a wide range of analyses. These analyses have shown that the cUTI diagnosis covers many different infections in different patient groups with very different outcomes.

    Miquel Pujol - Academic Lead RESCUING, Bellvitge University Hospital, Barcelona

Besides characterizing pathogens and resistance, the study team collected much more data from the 1006 enrolled patients with cUTIs. The data provided detailed insights into demographical and clinical characteristics of cUTI patients in intensive care, risk factors associated with cUTI development, early treatment failures and mortality, and current patient management in the hospitals and costs associated with such multi-resistant infections.

Scientific impact

These results were collected in six scientific papers (listed below) published in journals such as BMJ Open, IDSA Clinical Infectious Diseases, Antimicrobial Resistance & Infection Control and DovePress Infection and Drug Resistance.

The study team of RESCUING also presented the results at different conferences such as European Conference for Clinical Microbiology and Infectious Diseases (ECCMID), International Conference on Prevention and Infection Control (ICPIC) or the Healthcare Infection Society International Conference between 2017 and 2019.

Publications on Results from RESCUING

01/10/2020

COMBACTE-MAGNET and -NET Posters at IDWeek

03/09/2020

COMBACTE-MAGNET Patient and Public Involvement Survey

29/05/2020

EVADE Database Lock: Central Laboratory Data