Clinical study
Yiqi Huoxue Jiedu Formula Combined With Bacteriophages in the Treatment of Severe Pneumonia
| Status | Not yet recruiting |
|---|---|
| Type | Trial |
| Countries | China |
| Conditions studied | Pneumonia |
| Study years | 2026 (estimated)–2029 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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.
Study description
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.
Study registrations
| ClinicalTrials.gov | NCT07612605 |
|---|
Recorded study locations (4)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
The First Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, China
Recorded site status: Not separately listed. Study location source ↗
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangdong, Guangzhou, China
Recorded site status: Not separately listed. Study location source ↗
1st Medical Center of Chinese PLA General Hospital
Beijing, China
Recorded site status: Not separately listed. Study location source ↗
8th Medical Center of Chinese PLA General Hospital
Beijing, China
Recorded site status: Not separately listed. Study location source ↗
Related programs(3)
First Affiliated Hospital of Guangzhou Medical University
Intake unconfirmed
Recorded program–study link. Website
First Affiliated Hospital of Guangzhou University of Chinese Medicine
Intake unconfirmed
Recorded program–study link. Website
Chinese PLA General Hospital (First and Eighth Medical Centers)
Intake unconfirmed
Recorded program–study link. Website
Notes from the source review
- Possible overlap with NCT07338123. Keep both record IDs for audit; do not assume two distinct available treatment opportunities.
- Possible overlapping Chinese phage/herbal pneumonia protocols; identity not confirmed. Kept separate.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct07612605 |
|---|