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

NCT07206745 | Not Yet Recruiting DMC

• 1 other identifier: TCM for MDR-GNB pneumonia
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Severe pneumonia; multidrug-resistant Gram-negative bacterial infection; traditional Chinese medicine; randomized controlled trial; Fei Re Qing Granules

Outcome Measures

Primary Outcomes (1)

• 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.

  All-cause mortality: assessed at 14 and 28 days post-enrollment.

Secondary Outcomes (8)

• 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

Study Arms (2)

Test group

EXPERIMENTAL

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

Drug: Fei Re Qing Granules

Control group

PLACEBO COMPARATOR

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

Drug: Placebo of Feireqing Granules

Interventions

Fei Re Qing Granules 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.

Test group

Placebo of Feireqing Granules 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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• Henan Provincial Hospital of TCM: collaborator
• Third Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• Henan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiansheng Li, Doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Zhenzhen Feng, Doctor

CONTACT

+86 15890658268; huxifzz@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09