Meropenem and PralurbactamBest Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
Meropenem and Pralurbactam: 3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL/min)
Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam): The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form
Exclusion Criteria:
* 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.
* Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices
Primary outcome measure(s)
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)] — 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] — Day 28
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects] — at Test of Cure (TOC) visit (Day 10-23
Trial sites (1)
Facility
City
Region
Status
Huashan Hospital, Fudan Universit
Shanghai
China
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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