NCT07338123
Not yet recruiting
Early Phase 1
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 sites240 target enrollmentStarted: February 1, 2026Last updated:
Overview
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 240
- Primary Endpoint
- Clearance rate of drug-resistant bacteria
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
YHDF Placebo + Bacteriophage Placebo Group
Placebo Comparator
Intervention: YHDF Placebo (Drug)
YHDF Placebo + Bacteriophage Placebo Group
Placebo Comparator
Intervention: Bacteriophage Placebo (Drug)
YHDF Placebo + Bacteriophage Group
Placebo Comparator
Intervention: YHDF Placebo (Drug)
YHDF Placebo + Bacteriophage Group
Placebo Comparator
Intervention: Bacteriophage (Drug)
YHDF Drug + Bacteriophage Placebo Group
Placebo Comparator
Intervention: YHDF Drug (Drug)
YHDF Drug + Bacteriophage Placebo Group
Placebo Comparator
Intervention: Bacteriophage Placebo (Drug)
YHDF Drug + Bacteriophage Group
Experimental
Intervention: YHDF Drug (Drug)
YHDF Drug + Bacteriophage Group
Experimental
Intervention: Bacteriophage (Drug)
Outcomes
Primary Outcomes
Clearance rate of drug-resistant bacteria
Time Frame: 14 days
Secondary Outcomes
- Time to clinical improvement(7 days)
- All-cause mortality(28 days)
Investigators
wang kaifei
Chief Physician
Chinese PLA General Hospital
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