Bloodstream Infection (BSI), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Conditions
Brief 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).
Interventions
3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL/min)
DRUGBest 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.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHaihui Huang, PhD
Outcome results
None listed