A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections

NCT ID: NCT07206745

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-31

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:

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.

Conditions

Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test group

The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).

Group Type: EXPERIMENTAL

Fei Re Qing Granules

Intervention Type: DRUG

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.

Control group

The patients in the control group received routine standard treatments, and Placebo granules

Group Type: PLACEBO_COMPARATOR

Placebo of Feireqing Granules

Intervention Type: DRUG

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.

Interventions

Fei Re Qing Granules

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.

Intervention Type: DRUG

Placebo of Feireqing Granules

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial Hospital of TCM

UNKNOWN

Sponsor Role: collaborator

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiansheng Li, Doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Central Contacts

Zhenzhen Feng, Doctor

Role: CONTACT

huxifzz@163.com

+86 15890658268

Other Identifiers

TCM for MDR-GNB pneumonia

Identifier Type: -

Identifier Source: org_study_id