MEROPENEM ANHYDROUS for Bacteremia|Bloodstream infection due to cephalosporin-resistant Enterobacteriaceae

Inclusion criteria

• {"criterion_text":"- 1. Adults (age ≥ 18 years)\n- 2. New onset BSI due to E. coli,Klebsiella spp., Serratia marcescens, Providencia spp., Morganella morganii, Citrobacter freundii, and Enterobacter spp.in one or more blood cultures associated with evidence of infection.\n- 3. The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods).\n- 4. Both community and hospital-acquired bacteremias will be included.\n- 5. We will permit the inclusion of bacteremias due to study pathogens with concomitant growth in blood of skin commensals considered as contaminants."}

Exclusion criteria

• {"criterion_text":"- 1. More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).\n- 2. Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode.\n- 3. Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.\n- 4. Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure < 90 mmHg and/or use of vasopressors (dopamine>15μg/kg/min, adrenalin>0.1μg/kg/min, noradrenalin>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure <90 would need to represent a deviation for the patient’s known normal blood pressure.\n- 5. BSI due to specific infections known at the time of randomization: a. Endocarditis / endovascular infections b. Osteomyelitis (not resected) c. Central nervous system infections\n- 6. Allergy to any of the study drugs confirmed by history taken by the Investigator\n- 7. Previous enrollment in this trial\n- 8. Concurrent participation in another interventional clinical trial\n- 9. Imminent death (researcher’s assessment of expected death within 48 hrs. of recruitment) or patient in palliative care"}

Primary endpoints

• {"endpoint_text":"- Treatment failure at day 7 from randomization. Treatment modifications before day 7 will be discouraged, but they will be allowed according to treating physicians’ discretion","definition_or_measurement_approach":"Treatment failure at day 7 from randomization; treatment modifications before day 7 discouraged but allowed at treating physicians’ discretion."}

Secondary endpoints

• {"endpoint_text":"- •All-cause mortality 14,30,90days •Treatment failure 7,14,30days •Microbiological failure 7,14days •Relapse 30,90days •Clostridium difficile associated diarrhea till 90days •Development of either clinically or microbiologically documented infection other than Gram-negative bacteremia within 90days •Number of hospital re-admissions until day90","definition_or_measurement_approach":"Endpoints measured at specified timepoints (14, 30, 90 days for mortality; treatment failure at 7, 14, 30 days; microbiological failure at 7, 14 days; relapse at 30, 90 days; C. difficile associated diarrhea until 90 days; development of other documented infections within 90 days; number of hospital re-admissions until day 90)."}
• {"endpoint_text":"- •Development of resistance •Carriage of carbapenemase-producing Enterobacteriaceae and non-CPE CRE in-hospital till day90 •Total in-hospital days within 30,90days •Total antibiotic days within 30,90days •Adverse events at 30days","definition_or_measurement_approach":"Development/carriage of resistant organisms assessed up to day 90; total in-hospital days and total antibiotic days measured within 30 and 90 days; adverse events assessed at 30 days."}

Italy

Earliest CTIS Part Ii Submission Date

19-08-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

62

Number Of Sites

18

Number Of Participants

490

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy