A41.51 A41.52 A41.58
Conditions
Interventions
Group 1: Arm 1 (case group):
Adult patients (= 18 years) with monomicrobial bloodstream infection (BSI) caused by a multidrug-resistant gram-negative target pathogen (MDR-GN: E. coli or K. pneumoniae
P. aeruginosa according to the KRINKO definition 3MRGN/4MRGN). Only data from routine clinical care are collected (demographic, clinical, and microbiological findings from the hospital information sys
no additional blood draws or interventions take place. If written informed consent is available, a retrospective assessment of health-related quality of life (EQ-5D-5L) and cognitive function (Six-Ite
follow-up after 6 months).
Sponsors
UKSH Campus Lübeck, Institut für Medizinische Mikrobiologie, Klinik für Infektiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients with monomicrobial bloodstream infection (bacteremia) caused by one of the target pathogens Escherichia coli, Klebsiella pneumoniae, or Pseudomonas aeruginosa, detected in at least one blood culture obtained as part of routine clinical care. Prospective inclusion of all newly identified cases from the start of the study (July 1, 2025) over a recruitment period of twelve months.
Exclusion criteria
Exclusion criteria: Polymicrobial bloodstream infection (detection of more than one clinically relevant pathogen in blood cultures within seven days). Death within 24 hours after the blood culture request. Decision against antibiotic therapy. Patients from the departments of ophthalmology, pediatrics, or psychiatry/psychosomatic medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 14-day mortality (all-cause mortality): death from any cause within 14 days after the index blood culture. The vital status is assessed on day 14 after collection of the index blood culture via the hospital information system (HIS); if information is missing, follow-up is carried out as part of the regular follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month mortality (all-cause mortality): death from any cause within six months after the index blood culture, assessed six months after study enrollment as part of the telephone or written follow-up; if contact is not possible, alternatively via the HIS or the general practitioner. Length of hospital stay in days (admission to discharge or death), assessed at discharge from HIS routine data. Length of intensive care unit stay in days (cumulative ICU days), assessed at discharge from HIS routine data. Duration of ventilation in days (invasive ventilation), assessed at discharge from HIS routine data. Time to adequate antibiotic therapy in hours (from the time of blood culture to the administration of an effective antibiotic according to EUCAST), assessed continuously during the inpatient stay from HIS/prescription data. Persistence of bacteremia (positive blood culture = 48 hours after the start of therapy), assessed continuously during the inpatient stay from microbiological findings. Complications (septic shock, organ failure, disseminated intravascular coagulation [DIC], reinfection), assessed during the inpatient stay (days 0, 14, 28) from HIS routine data. Health-related quality of life, assessed with the EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels) at two time points: retrospectively during the inpatient stay (referring to the state before the event leading to admission) and six months after discharge. Cognitive function, assessed with the SIS (Six-Item Screener) at the same two time points (inpatient and six months after discharge). Direct inpatient treatment costs, determined by the hospital's internal controlling department at the (pseudonymized) case-number level, assessed after discharge. | — |
Countries
Germany
Contacts
Public ContactJan Rupp
UKSH Campus Lübeck, Institut für Medizinische Mikrobiologie, Klinik für Infektiologie
Outcome results
None listed