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.
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.
“RESCUING provided a great opportunity for me to step out of my daily business tasks and work closely together with the RESCUING team on this project which would not be feasible without the support of IMI for COMBACTE-MAGNET. The project clearly highlighted the urgent need on public private partnerships between academic and industry sectors to combat together current antimicrobial resistance and other pandemics in the future.”
Publications on Results from RESCUING
- Gomila A., Carratalà J., Eliakim-Raz N., Shaw E., Tebé C., Wolkewitz M., Wiegand I., Grier S., Vank C., Cuperus N., et al. Clinical outcomes of hospitalised patients with catheter-associated urinary tract infection in countries with a high rate of multidrug-resistance: The COMBACTE-MAGNET RESCUING study. Antimicrob Resist Infect Control. 2019 Dec 3;8:198.
- Gomila A, Carratalà J, Eliakim-Raz N, Shaw E, Wiegand I, Vallejo-Torres L, Gorostiza A, Vigo J M, Morris S, Stoddart M, et al. Risk Factors and Prognosis of Complicated Urinary Tract Infections Caused by Pseudomonas aeruginosa in Hospitalized Patients: a Retrospective Multicenter Cohort Study. Infection and Drug Resistance. 2018;11:2571–2581.
- Gomila A, Shaw E, Carratalà J, Leibovici L, Tebé C, Wiegand I, Vallejo-Torres L, Vigo JM, Morris S, Stoddart M, et al. Predictive Factors for Multidrug-Resistant Gram-Negative Bacteria Among Hospitalised Patients with Complicated Urinary Tract Infections. Antimicrob Resist Infect Control. 2018;7:111.
- Eliakim-Raz N., Babitch T., Shaw E., Addy I., Wiegand I., Vank C., Torre-Vallejo L., Vigo J.M., Morris S., Grier S., et al. Risk Factors for Treatment Failure and Mortality Among Hospitalized Patients With Complicated Urinary Tract Infection: A Multicenter Retrospective Cohort Study (RESCUING Study Group). Clin Infect Dis. 2019 Jan 1;68(1):29-36.
- Vallejo-Torres L., Pujol M., Shaw E., Wiegand I., Vigo J.M., Stoddart M., Grier S., Gibbs J., Vank C., Cuperus N., et al. Cost of Hospitalised Patients Due to Complicated Urinary Tract Infections: A Retrospective Observational Study in Countries with High Prevalence of Multidrug-resistant Gram-negative Bacteria: The COMBACTE-MAGNET, RESCUING Study. BMJ Open. 2018;8(4):e020251.
- Shaw E., Addy I., Stoddart M., Vank C., Grier S., Wiegand I., Leibovici L., Eliakim-Raz N., Vallejo-Torres L., Morris S., et al. 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 (RESCUING). BMJ Open. 2016;6(7):e011500.