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).
Hospitalized male or female≥18 and ≤80 years of age，
Participant must have a diagnosis of an infection (HABP/VABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy
Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy
The estimated survival time is more than 28 days
Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
Participant is expected to require more than 21 days of treatment
Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 using the most recent available data
Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Parallel
Meropenem and Pralurbactam
Drug3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL/min)
Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
DrugThe main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]
Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]
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