An interventional study of Fei Re Qing Granules and Placebo of Feireqing Granules in Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection, sponsored by Henan University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 152 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The patients in the control group received routine standard treatments, and Placebo granules
Drug: Placebo of Feireqing 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.
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.
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
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Henan University of Traditional Chinese Medicine