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NCT Number: NCT07612605

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangdong, Guangzhou, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YHDF Placebo

Drug

7-14 days treatment with YHDF placebo

Bacteriophage Placebo

Drug

7-14 days treatment with bacteriophage placebo

YHDF Drug

Drug

7-14 days treatment with YHDF

Bacteriophage

Drug

7-14 days treatment with bacteriophage

Primary outcomes

  1. Clearance rate of drug-resistant bacteria

    Time frame: 14 days

Secondary outcomes

  1. Time to clinical improvement

    Time frame: 7 days

  2. All-cause mortality

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Congyang Zheng

CONTACT

[email protected]

8618323063716

Jianqiao Xu

CONTACT

[email protected]

8617310692712

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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