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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат YHDF placebo
  7-14 days treatment with YHDF placebo
• Препарат Bacteriophage Placebo
  7-14 days treatment with bacteriophage placebo
• Препарат YHDF Drug
  7-14 days treatment with YHDF
• Препарат Bacteriophage
  7-14 days treatment with bacteriophage

Первичные конечные точки

• Clearance rate of drug-resistant bacteria [Срок оценки: 14 days]

Вторичные конечные точки (2)

• Time to clinical improvement [Срок оценки: 7 days]
• All-cause mortality [Срок оценки: 28 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• The First Affiliated Hospital of Guangzhou Medical University — Guangdong
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangdong
• 1st Medical Center of Chinese PLA General Hospital — Пекин
• 8th Medical Center of Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07612605 · 2025ZD05493-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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