Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial InfectionNCT07206745
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
A study testing Fei Re Qing Granules in people with Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
- What is being tested?
- Fei Re Qing Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
贞贞 冯, DOCTOR, +086 15890658268, huxifzz@163.com
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Fei Re Qing Granules, Placebo of Feireqing Granules
- Keywords
- Severe pneumonia, multidrug-resistant Gram-negative bacterial infection, traditional Chinese medicine, randomized controlled trial, Fei Re Qing Granules
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fei Re Qing GranulesDrug
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 GranulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Fei Re Qing Granules |
| Control group | Placebo comparator | The patients in the control group received routine standard treatments, and Placebo granules Receives: Drug: Placebo of Feireqing Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All-cause mortality: assessed at 14 and 28 days post-enrollment.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 0 of treatment to Day 28 of follow-up
Length of hospital stay
Total number of days of hospitalization
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 0 of treatment to Day 28 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial Hospital of TCM, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, Doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206745
- Sponsor's protocol ID
- TCM for MDR-GNB pneumonia
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07206745
- Acronym / sponsor ID
- TCM for MDR-GNB pneumonia
- Keywords
- Severe pneumonia, multidrug-resistant Gram-negative bacterial infection, traditional Chinese medicine, randomized controlled trial, Fei Re Qing Granules
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Henan Provincial Hospital of TCM, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Fei Re Qing GranulesThe patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day). |
| Control group | Placebo comparator | Drug: Placebo of Feireqing GranulesThe patients in the control group received routine standard treatments, and Placebo granules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fei Re Qing GranulesFei 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. | Drug | Test group |
| Placebo of Feireqing GranulesPlacebo 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. | Drug | Control group |
Primary outcome
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.
8 secondary outcomes
Clinical cure rate
Time frame: Evaluations will be conducted on treatment Day 0, Day 14 and during follow-up on Day 28.
Bacterial clearance rate
Time frame: Treatment days 0, days 7, and days 14.
Duration of antibiotic use
Time frame: From Day 0 of treatment to Day 28 of follow-up
Invasive mechanical ventilation rate
Time frame: From Day 0 of treatment to Day 28 of follow-up
Length of hospital stay
Time frame: From Day 0 of treatment to Day 28 of follow-up
Clinical Pulmonary Infection Score (CPIS)
Time frame: Assessed on treatment days 0, 7, and 14, and on follow-up days 14 and 28.
SOFA score
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
Time frame: From Day 0 of treatment to Day 28 of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiansheng Li, Doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fei Re Qing Granules in people with Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Feng, Doctor (+86 15890658268, huxifzz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: All-cause mortality: assessed at 14 and 28 days post-enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.