Yiqi Huoxue Jiedu Formula Combined With Bacteriophages in the Treatment of Severe Pneumonia

NCT07612605 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025ZD05493-3
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

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

Keywords

bacteriophage; Yiqi Huoxue Jiedu Formula; drug-resistant bacteria; 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

7-14 days treatment with YHDF placebo, 7-14 days treatment with phage placebo

Drug: YHDF placebo; Drug: Bacteriophage Placebo

YHDF Placebo + Bacteriophage Group

ACTIVE COMPARATOR

7-14 days treatment with YHDF placebo, 7-14 days treatment with phage placebo

Drug: YHDF placebo; Drug: Bacteriophage

YHDF Drug + Bacteriophage Placebo Group

ACTIVE COMPARATOR

7-14 days treatment with YHDF, 7-14 days treatment with phage placebo

Drug: Bacteriophage Placebo; Drug: YHDF Drug

YHDF Drug + Bacteriophage Group

ACTIVE COMPARATOR

7-14 days treatment with YHDF, 7-14 days treatment with phage

Drug: YHDF Drug; Drug: Bacteriophage

Interventions

YHDF placebo DRUG

7-14 days treatment with YHDF placebo

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

Bacteriophage Placebo DRUG

7-14 days treatment with bacteriophage placebo

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

YHDF Drug DRUG

7-14 days treatment with YHDF

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

Bacteriophage DRUG

7-14 days treatment with bacteriophage

YHDF Drug + Bacteriophage Group; YHDF Placebo + Bacteriophage Group

Eligibility Criteria

• Age: 18 Years - 85 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

Study Sites (4)

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangdong, Guangzhou, China

Location

1st Medical Center of Chinese PLA General Hospital

Beijing, China

Location

8th Medical Center of Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Lixin Xie

  College of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Jianqiao Xu

CONTACT

8617310692712; 774690118@qq.com

Congyang Zheng

CONTACT

8618323063716; zhengcy1025@outlook.com

Study Design

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

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)