NCT07338123尚未招募1 期
A Randomized Controlled Trial (RCT) of Yiqi Huoxue Jiedu Formula Combined With Bacteriophages in the Treatment of Severe Pneumonia Caused by Drug-resistant Gram-negative Bacilli
Chinese PLA General Hospital0 个研究点目标入组 240 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Clearance rate of drug-resistant bacteria
研究概览
简要总结
Through a prospective randomized controlled trial, we systematically evaluate the effects of Yiqi Huoxue Jiedu Formula combined with bacteriophage therapy on the bacterial clearance rate, disease improvement rate and mortality rate in patients with severe pneumonia caused by drug-resistant bacteria, so as to clarify its clinical transformation value.
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
- Double (Participant, Care Provider)
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
- •Patients who meet the diagnostic criteria for severe pneumonia caused by drug-resistant Gram-negative bacilli and conform to the TCM syndrome differentiation of Qi deficiency, toxin accumulation and blood stasis syndrome; patients confirmed by rapid on-site microbiological evaluation (M-ROSE), clinical microbial culture and drug susceptibility testing (based on the drug susceptibility test results of our hospital or other Grade A tertiary hospitals) to be infected with multidrug-resistant Klebsiella pneumoniae, Acinetobacter baumannii or Pseudomonas aeruginosa; aged 18 to 85 years old; patients or their family members agree to cooperate with the collection of upper and lower respiratory tract specimens, consent to bronchoscopy plus bronchoalveolar lavage, and agree to receive nebulized inhalation of bacteriophage therapy; patients or their family members have fully read, understood and signed the informed consent form.
排除标准
- •Women who are pregnant or lactating; patients with immunodeficiency; patients receiving immunosuppressive therapy or suffering from immunodeficiency diseases; patients who have received mechanical ventilation for more than 60 days prior to enrollment; patients with active pulmonary tuberculosis, lung abscess, or Grade D chronic obstructive pulmonary disease (COPD); patients with incomplete sampling or clinical data; patients with known allergies to bacteriophage products or the components of Yiqi Huoxue Jiedu Formula; patients judged by the researchers as unsuitable for participation in this study.
研究组 & 干预措施
YHDF Placebo + Bacteriophage Placebo Group
Placebo Comparator
干预措施: YHDF Placebo (Drug)
YHDF Placebo + Bacteriophage Placebo Group
Placebo Comparator
干预措施: Bacteriophage Placebo (Drug)
YHDF Placebo + Bacteriophage Group
Placebo Comparator
干预措施: YHDF Placebo (Drug)
YHDF Placebo + Bacteriophage Group
Placebo Comparator
干预措施: Bacteriophage (Drug)
YHDF Drug + Bacteriophage Placebo Group
Placebo Comparator
干预措施: YHDF Drug (Drug)
YHDF Drug + Bacteriophage Placebo Group
Placebo Comparator
干预措施: Bacteriophage Placebo (Drug)
YHDF Drug + Bacteriophage Group
Experimental
干预措施: YHDF Drug (Drug)
YHDF Drug + Bacteriophage Group
Experimental
干预措施: Bacteriophage (Drug)
结局指标
主要结局
Clearance rate of drug-resistant bacteria
时间窗: 14 days
次要结局
- Time to clinical improvement(7 days)
- All-cause mortality(28 days)
研究者
wang kaifei
Chief Physician
Chinese PLA General Hospital
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