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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2029-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia

NCT07202234

VAP - Ventilator Associated Pneumonia

NOT_YET_RECRUITING NA

Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia

NCT06370598

Pneumonia, Ventilator-Associated

NOT_YET_RECRUITING PHASE1/PHASE2

PREDICATE Trial For Respiratory Tract Infections

NCT06472219

Respiratory Tract Infections

RECRUITING PHASE3

Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia

NCT06747325

Community-Acquired Pneumonia (CAP)

NOT_YET_RECRUITING NA

Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.

NCT07086391

Carbapenem-Resistant Enterobacteriaceae Infection Pneumonia - Bacterial

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

YHDF Placebo + Bacteriophage Placebo Group

Group Type PLACEBO_COMPARATOR

YHDF Placebo

Intervention Type DRUG

7-day treatment with YHDF placebo

Bacteriophage Placebo

Intervention Type DRUG

7-14-day treatment with phage placebo

YHDF Placebo + Bacteriophage Group

Group Type PLACEBO_COMPARATOR

YHDF Placebo

Intervention Type DRUG

7-day treatment with YHDF placebo

Bacteriophage

Intervention Type DRUG

7-14-day treatment with phage

YHDF Drug + Bacteriophage Placebo Group

Group Type PLACEBO_COMPARATOR

YHDF Drug

Intervention Type DRUG

7-day treatment with YHDF Drug

Bacteriophage Placebo

Intervention Type DRUG

7-14-day treatment with phage placebo

YHDF Drug + Bacteriophage Group

Group Type EXPERIMENTAL

YHDF Drug

Intervention Type DRUG

7-day treatment with YHDF Drug

Bacteriophage

Intervention Type DRUG

7-14-day treatment with phage

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

YHDF Drug

7-day treatment with YHDF Drug

Intervention Type DRUG

YHDF Placebo

7-day treatment with YHDF placebo

Intervention Type DRUG

Bacteriophage

7-14-day treatment with phage

Intervention Type DRUG

Bacteriophage Placebo

7-14-day treatment with phage placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No