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
Sponsor study identifier
interventional
152
1 country
1
Study Start
December 1, 2025
Actual (reported)Primary Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2025
Actual (reported)October 3, 2025
Actual (reported)December 1, 2025
Actual (reported)September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).
The patients in the control group received routine standard treatments, and Placebo 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.
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.
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
Jiansheng Li, Doctor
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First Submitted
September 24, 2025
First Posted
October 3, 2025
Study Start
December 1, 2025
Actual (reported)Primary Completion
September 30, 2027
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 9, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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