The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
3g,q8h,180min infusion,Dose adjustments are available for participants with eGFR(mL/min)
The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.
Huashan Hospital, Fudan Universit
Shanghai, China
RECRUITINGProportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]
Time frame: at Test of Cure (TOC) visit (Day 12-23)
Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]
Time frame: Day 28
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]
Time frame: at Test of Cure (TOC) visit (Day 10-23
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