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

NCT07338123 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025ZD0549303
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Clearance rate of drug-resistant bacteria

  14 days

Secondary Outcomes (2)

• Time to clinical improvement

  7 days

• All-cause mortality

  28 days

Study Arms (4)

YHDF Placebo + Bacteriophage Placebo Group

PLACEBO COMPARATOR

Drug: YHDF Placebo; Drug: Bacteriophage Placebo

YHDF Placebo + Bacteriophage Group

PLACEBO COMPARATOR

Drug: YHDF Placebo; Drug: Bacteriophage

YHDF Drug + Bacteriophage Placebo Group

PLACEBO COMPARATOR

Drug: YHDF Drug; Drug: Bacteriophage Placebo

YHDF Drug + Bacteriophage Group

EXPERIMENTAL

Drug: YHDF Drug; Drug: Bacteriophage

Interventions

YHDF Drug DRUG

7-day treatment with YHDF Drug

YHDF Drug + Bacteriophage Group; YHDF Drug + Bacteriophage Placebo Group

YHDF Placebo DRUG

7-day treatment with YHDF placebo

YHDF Placebo + Bacteriophage Group; YHDF Placebo + Bacteriophage Placebo Group

Bacteriophage DRUG

7-14-day treatment with phage

YHDF Drug + Bacteriophage Group; YHDF Placebo + Bacteriophage Group

Bacteriophage Placebo DRUG

7-14-day treatment with phage placebo

YHDF Drug + Bacteriophage Placebo Group; YHDF Placebo + Bacteriophage Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01