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

Sponsor
Chinese PLA General Hospital
Study ID
NCT07338123
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • YHDF Drug — DRUG
    7-day treatment with YHDF Drug
  • YHDF Placebo — DRUG
    7-day treatment with YHDF placebo
  • Bacteriophage — DRUG
    7-14-day treatment with phage
  • Bacteriophage Placebo — DRUG
    7-14-day treatment with phage placebo

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Feb 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: YHDF Placebo + Bacteriophage Placebo Group
  • Placebo Comparator: YHDF Placebo + Bacteriophage Group
  • Placebo Comparator: YHDF Drug + Bacteriophage Placebo Group
  • Experimental: YHDF Drug + Bacteriophage Group

Primary Outcome Measure

Clearance rate of drug-resistant bacteria [ Time Frame: 14 days ]

Related Studies