Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI), Bloodstream Infection (BSI)
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