NCT06841731招募中2 期
A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of HRS-8427 in the Treatment of Adults With Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The all-cause mortality rate at Day 14.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol.
- •Male and female, ≥18 years.
- •Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.
- •All subjects must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia.
- •Women of childbearing potential must have a negative serum pregnancy test before the first dose and must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth and sperm/ovum donation from the time of signing the informed consent form (ICF) till 14 days after the end of treatment.
排除标准
- •Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
- •Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
- •HABP or VABP caused by obstruction.
- •Subjects who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization.
- •Impairment of renal function with estimated glomerular filtration rate < 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
- •Subjects with significant laboratory abnormalities.
- •Other pulmonary diseases that may confound the assessment of efficacy or safety.
- •Known history of immune deficiency disease or receive immunocompromising treatment.
- •Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.
- •Known or suspected central nervous system infections.
- •Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.
- •Drug abuse within 1 year prior to randomization.
- •Judged by the Investigator, other reasons unsuitable for this study.
研究组 & 干预措施
HRS-8427
Experimental
干预措施: HRS-8427 (Drug)
Meropenem
Active Comparator
干预措施: Meropenem (Drug)
结局指标
主要结局
The all-cause mortality rate at Day 14.
时间窗: From the first dose of the study drug to Day 14.
次要结局
- The all-cause mortality rate at Day 28.(From the first dose of the study drug to Day 28.)
- The total ventilation time.(Day 21 to Day 28.)
- The percentage of participants with microbiologic eradication at the early assessment (EA) period.(Day 4 after the start of the treatment.)
- The percentage of participants with microbiologic eradication at the end of treatment (EOT) period.(Day 7 to 14.)
- The percentage of participants with microbiologic eradication at the follow-up (FU) period.(Day 21 to 28.)
- The percentage of participants with microbiologic eradication at the test of cure (TOC) period.(Day 14 to 21.)
研究者
研究点 (1)
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