Clinical Research Directory

Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates

Sepsis and bloodstream infection (BSI) are among the most serious complications in patients with cancer, in whom disease- and treatment-related immunosuppression markedly increases susceptibility to infection. Sepsis accounts for approximately 15% of ICU admissions in this population, and short-term mortality is consistently higher than in patients without cancer In haematological malignancy, sepsis affects roughly 12-27% of patients within a year of diagnosis, and although in-hospital mortality has fallen over two decades, it remained higher than in non-cancer patients (23.1% vs 14.4% in 2021) .

EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

RAPID is an investigator initiated Phase 4, multinational, multicentre, open-label, randomised controlled superiority trial evaluating the clinical impact of rapid microbiological diagnostics combined with antimicrobial stewardship and early targeted antibiotic therapy compared with standard-of-care diagnostics and antibiotics. Hospitalised adult patients with bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia are randomised in a 1:1 ratio to the intervention or control arm. The main analysis population comprises patients with infections caused by Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales. A secondary analysis population includes patients with infections caused by other specified multidrug-resistant Gram-negative organisms. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice. The primary outcome is a composite of all-cause mortality or absence of improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14 following the index culture.

Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test

This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis. Participants enrolled in the study will have blood collected at the same time as blood samples obtained for standard-of-care blood culture testing. Study blood samples will be tested using the UllCORE BSI Test either as fresh samples or after frozen storage, according to the study protocol. The results of the UllCORE BSI Test will be compared with standard-of-care microbiology results and, when applicable, additional testing methods to assess the diagnostic performance of the investigational test. The UllCORE BSI Test results will not be used to guide patient care and will not be provided to treating healthcare professionals for clinical decision-making. Participation in the study will therefore not change the standard medical care received by participants.