Efficacy Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections: A Randomized, Double-Blind, Placebo-Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- All-cause mortality
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meeting the diagnostic criteria for severe pneumonia, aged ≥18 years and <80 years;
- •Microbiological culture confirming Gram-negative bacterial infection resistant to three or more classes of antibiotics, such as extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii (CRAB), and multidrug-resistant Pseudomonas aeruginosa (MDR-PA);
- •Written informed consent obtained from the patient or their legal representative.
Exclusion Criteria
- •Pregnant or breastfeeding women;
- •Patients with impaired consciousness, dementia, psychiatric disorders, or other conditions that preclude effective communication and cooperation;
- •Patients with aspiration pneumonia, fungal pneumonia, viral pneumonia, pulmonary tuberculosis, or HIV-associated Pneumocystis jirovecii pneumonia;
- •Patients with severe hepatic or renal insufficiency, such as liver cirrhosis with Child-Pugh score of 10-15, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²;
- •Patients with hematologic malignancies, solid organ transplantation, or congenital/acquired diseases leading to immunodeficiency;
- •Patients with multidrug-resistant bacterial infections outside the lung (e.g., urinary tract, abdominal cavity, bloodstream);
- •Patients with severe cardiac dysfunction (NYHA class IV), malignant arrhythmias, or other hemodynamically unstable conditions;
- •Patients who have already received antimicrobial therapy for more than one week;
- •Patients who have participated in another drug clinical trial within one month prior to enrollment;
- •Patients with known allergy to the investigational drug.
Arms & Interventions
Test group
The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).
Intervention: Fei Re Qing Granules (Drug)
Control group
The patients in the control group received routine standard treatments, and Placebo granules
Intervention: Placebo of Feireqing Granules (Drug)
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: All-cause mortality: assessed at 14 and 28 days post-enrollment.
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.
Secondary Outcomes
- Clinical cure rate(Evaluations will be conducted on treatment Day 0, Day 14 and during follow-up on Day 28.)
- Bacterial clearance rate(Treatment days 0, days 7, and days 14.)
- Duration of antibiotic use(From Day 0 of treatment to Day 28 of follow-up)
- Invasive mechanical ventilation rate(From Day 0 of treatment to Day 28 of follow-up)
- Length of hospital stay(From Day 0 of treatment to Day 28 of follow-up)
- Clinical Pulmonary Infection Score (CPIS)(Assessed on treatment days 0, 7, and 14, and on follow-up days 14 and 28.)
- SOFA score(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(From Day 0 of treatment to Day 28 of follow-up)