Meropenem and Pralurbactam: 3g,q8h,120min infusion
Ceftazidime-avibactam: 2.5g,q8h,120min infusion
Study summary
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. This study is a randomized, double-blind, active-controlled study. The total duration of the study will be approximately 32 days including screening and follow-up.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 1\. Male or female participants ≥18 and ≤80 years of age
2\. have a diagnosis of HAP/VAP.
3\. have systemic signs and respiratory signs or symptoms of HAP/VAP.
4\. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
5\. The estimated survival time is at lest 28 days.
Exclusion Criteria:
* 1\. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
2\. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
3\. Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30.
4\. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
5\. Those who have a history of drug abuse or drug abuse within 6 months before screening.
6\. 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 Who Died Due to Any Cause Description: Due to Day 14,Proportion of Participants Who Died Due to Any Cause in mITT — Day 14
Trial sites (1)
Facility
City
Region
Status
Hunan University Of Medicine General Hospital
Huaihua
Hunan
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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