This study aims to evaluate the clinical efficacy of a traditional Chinese medicine formula granule (Feireqing Granules) in the treatment of severe pneumonia caused by multidrug-resistant Gram-negative bacterial infections (MDR-GNB severe pneumonia), to establish a therapeutic regimen, and to generate high-quality clinical evidence.
This study evaluates the efficacy and safety of Feireqing Granules for MDR-GNB severe pneumonia through a multicenter, randomized, double-blind, placebo-controlled trial. Key elements of the trial include: Design: Conducted across multiple centers, comparing Feireqing Granules and placebo groups, alongside standard guideline-based modern medical treatment. Participants: Patients diagnosed with MDR-GNB severe pneumonia according to modern medical diagnostic criteria, aged ≥18 years and \<80 years. 76 patients will be enrolled in each group. Intervention: Test group: Participants will receive Feireqing Granules in combination with standard modern medical treatments. Control group: Participants will receive placebo granules (matching the appearance, weight, color, and odor of the active granules, composed mainly of starch, dextrin, microcrystalline cellulose, and 5% active drug) in combination with standard modern medical treatments. Outcomes: Primary efficacy indicator: All-cause mortality. Secondary indicators: Clinical cure rate, bacterial clearance rate, duration of antibiotic therapy, effective mechanical ventilation rate, length of hospital stay, Clinical Pulmonary Infection Score (CPIS), Acute Physiology and Chronic Health Evaluation II (APACHE II) score, and Sequential Organ Failure Assessment (SOFA) score. Study Duration: Treatment for 14 days, with a 28-day follow-up. This trial seeks to confirm the clinical efficacy of Feireqing Granules in treating MDR-GNB severe pneumonia and to provide high-quality evidence for the long-term and objective evaluation of TCM interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Fei Re Qing Granules (Ingredients: Scutellaria baicalensis \[Huang Qin\], Trichosanthes kirilowii \[Gua Lou\], Forsythia suspensa \[Lian Qiao\], Fritillaria thunbergii \[Zhe Bei Mu\], etc.). Routine standard treatments：Routine standard treatments according to clinical guidelines.
Placebo of Feireqing Granules：The placebo granules are prepared using 5% of the active drug combined with pharmaceutical excipients, including starch, dextrin, microcrystalline cellulose, and food-grade coloring and flavoring agents, to ensure consistency in appearance, weight, color, and odor with the Fei Re Qing Granules. Routine standard treatments：Routine standard treatments according to clinical guidelines.
All-cause mortality
All-cause mortality will be assessed as the proportion of participants who die from any cause during the study period. Mortality will be recorded at Day 14 and Day 28 after enrollment.
Time frame: All-cause mortality: assessed at 14 and 28 days post-enrollment.
Clinical cure rate
According to the Technical Guidelines for Clinical Trials of Antibacterial Drugs, clinical cure is defined as the complete resolution or normalization of all symptoms and signs present at baseline at the post-treatment visit, along with normalization of non-microbiological indicators such as imaging and laboratory tests. In practice, some clinical symptoms or signs, or abnormalities in non-microbiological indicators, may still be observed at the post-treatment visit. If these findings are physiological, reflect post-infection status, or are related to underlying diseases rather than active infection, they may also be considered indicative of clinical cure.
Time frame: Evaluations will be conducted on treatment Day 0, Day 14 and during follow-up on Day 28.
Bacterial clearance rate
Based on microbiological testing during hospitalization. Pathogen-targeted next-generation sequencing (tNGS) of bronchoalveolar lavage fluid or sputum, or sputum culture, is performed on treatment days 0, 7, and 14 for evaluation.
Time frame: Treatment days 0, days 7, and days 14.
Duration of antibiotic use
Total number of days of antibiotic therapy during hospitalization, including both intravenous and oral administration.
Time frame: From Day 0 of treatment to Day 28 of follow-up
Invasive mechanical ventilation rate
The invasive mechanical ventilation rate will be assessed as the proportion of participants who require invasive mechanical ventilation during the study period. Eligible participants are those not receiving invasive ventilation at baseline (Day 0). The outcome is defined as the need for endotracheal intubation and mechanical ventilation due to clinical deterioration, including worsening hypoxemia, hypercapnia, or respiratory failure. The rate will be calculated as the number of participants requiring invasive mechanical ventilation divided by the total number of participants at risk, from Day 0 of treatment to Day 28 of follow-up.
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Enrollment
152
Time frame: From Day 0 of treatment to Day 28 of follow-up
Length of hospital stay
Total number of days of hospitalization
Time frame: From Day 0 of treatment to Day 28 of follow-up
Clinical Pulmonary Infection Score (CPIS)
The Clinical Pulmonary Infection Score (CPIS) will be used to evaluate the presence and severity of pulmonary infection. The CPIS is calculated based on a composite of clinical, radiological, and laboratory parameters, including body temperature, leukocyte count, tracheal secretions, oxygenation (PaO₂/FiO₂), chest radiograph findings, and culture results of tracheal aspirate. Each component is scored from 0 to 2 points, with a maximum total score of 12; higher scores indicate more severe infection. CPIS will be assessed on treatment days 0, 7, and 14, as well as on follow-up days 14 and 28.
Time frame: Assessed on treatment days 0, 7, and 14, and on follow-up days 14 and 28.
SOFA score
The Sequential Organ Failure Assessment (SOFA) score will be used to evaluate the extent of organ dysfunction during the study. The SOFA score includes six components: respiratory function (PaO₂/FiO₂ ratio), coagulation (platelet count), liver function (bilirubin), cardiovascular status (mean arterial pressure or vasopressor requirement), central nervous system function (Glasgow Coma Scale), and renal function (serum creatinine or urine output). Each organ system is scored from 0 (normal) to 4 (severe dysfunction), with a total score ranging from 0 to 24. Higher scores indicate more severe organ dysfunction and higher risk of mortality. SOFA scores will be assessed on treatment days 0, 7, and 14, and on follow-up days 14 and 28.
Time frame: Recorded on treatment days 0, 7, and 14, and on follow-up days 14 and 28.
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
The Acute Physiology and Chronic Health Evaluation II (APACHE II) score will be used to evaluate the severity of illness and the risk of mortality. The score incorporates the acute physiology score, age score, and chronic health score. Higher total scores indicate more severe illness and greater mortality risk. APACHE II scores will be recorded on treatment days 0, 7, and 14, and on follow-up days 14 and 28.
Time frame: From Day 0 of treatment to Day 28 of follow-up