PneumoniaEarly Phase 1NCT07612605
Yiqi Huoxue Jiedu Formula Combined With Bacteriophages in the Treatment of Severe Pneumonia
A Early Phase 1 study testing YHDF Drug and Bacteriophage in people with Pneumonia, run by Chinese PLA General Hospital at 4 sites in China.
Trial summary
Through a prospective randomized controlled trial, we systematically evaluate the effects of Yiqi Huoxue Jiedu Formula combined with bacteriophage therapy on the bacterial clearance rate, disease improvement rate and mortality rate in patients with severe pneumonia caused by drug-resistant bacteria, so as to clarify… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- YHDF Drug and Bacteriophage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria for severe pneumonia caused by drug-resistant Gram-negative bacilli and conform to the TCM syndrome differentiation of Qi deficiency, toxin accumulation and blood stasis syndrome;
- Patients confirmed by rapid on-site microbiological evaluation (M-ROSE), clinical microbial culture and drug susceptibility testing (based on the drug susceptibility test results of our hospital or other Grade A tertiary hospitals) to be infected with multidrug-resistant Klebsiella pneumoniae, Acinetobacter baumannii or Pseudomonas aeruginosa;
- Aged 18 to 85 years old;
- Patients or their family members agree to cooperate with the collection of upper and lower respiratory tract specimens, consent to bronchoscopy plus bronchoalveolar lavage, and agree to receive nebulized inhalation of bacteriophage therapy;
- Patients or their family members have fully read, understood and signed the informed consent form.
Who cannot join
- Women who are pregnant or lactating;
- Patients with immunodeficiency;
- Patients receiving immunosuppressive therapy or suffering from immunodeficiency diseases;
- Patients who have received mechanical ventilation for more than 60 days prior to enrollment;
- Patients with active pulmonary tuberculosis, lung abscess, or Grade D chronic obstructive pulmonary disease (COPD);
- Patients with incomplete sampling or clinical data;
- Patients with known allergies to bacteriophage products or the components of Yiqi Huoxue Jiedu Formula;
- Patients judged by the researchers as unsuitable for participation in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
1st Medical Center of Chinese PLA General Hospital
Beijing
Jianqiao Xu, 8617310692712, 774690118@qq.com
8th Medical Center of Chinese PLA General Hospital
Beijing
Congyang Zheng, 8618323063716, zhengcy1025@outlook.com
The First Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou
Yin Xi, 8618620623001, xiyjn86@163.com
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangdong, Guangzhou
Fengli Zhao, 8613925118896, alpszf@163.com
About this study
Official title: A Randomized Controlled Trial (RCT) of Yiqi Huoxue Jiedu Formula Combined With Bacteriophages in the Treatment of Severe Pneumonia Caused by Drug-resistant Gram-negative Bacilli
Through a prospective randomized controlled trial, we systematically evaluate the effects of Yiqi Huoxue Jiedu Formula combined with bacteriophage therapy on the bacterial clearance rate, disease improvement rate and mortality rate in patients with severe pneumonia caused by drug-resistant bacteria, so as to clarify its clinical transformation value.
- Conditions
- Pneumonia
- Being tested
- YHDF placebo, Bacteriophage Placebo, YHDF Drug, Bacteriophage
- Keywords
- bacteriophage, Yiqi Huoxue Jiedu Formula, drug-resistant bacteria, Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHDF placeboDrug
7-14 days treatment with YHDF placebo
Bacteriophage PlaceboDrug
7-14 days treatment with bacteriophage placebo
YHDF DrugDrug
7-14 days treatment with YHDF
BacteriophageDrug
7-14 days treatment with bacteriophage
| Study group | Role | What they receive |
|---|---|---|
| YHDF Placebo + Bacteriophage Placebo Group | Placebo comparator | 7-14 days treatment with YHDF placebo, 7-14 days treatment with phage placebo Receives: Drug: YHDF placebo; Drug: Bacteriophage Placebo |
| YHDF Placebo + Bacteriophage Group | Active comparator | 7-14 days treatment with YHDF placebo, 7-14 days treatment with phage placebo Receives: Drug: YHDF placebo; Drug: Bacteriophage |
| YHDF Drug + Bacteriophage Placebo Group | Active comparator | 7-14 days treatment with YHDF, 7-14 days treatment with phage placebo Receives: Drug: Bacteriophage Placebo; Drug: YHDF Drug |
| YHDF Drug + Bacteriophage Group | Active comparator | 7-14 days treatment with YHDF, 7-14 days treatment with phage Receives: Drug: YHDF Drug; Drug: Bacteriophage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate of drug-resistant bacteria
Measured: 14 days
Secondary outcomes (2)
Time to clinical improvement
Measured: 7 days
All-cause mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixin Xie, Chinese PLA General Hospital
- Investigators
- Lixin Xie, Study director, College of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612605
- Sponsor's protocol ID
- 2025ZD05493-3
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) of Yiqi Huoxue Jiedu Formula Combined With Bacteriophages in the Treatment of Severe Pneumonia Caused by Drug-resistant Gram-negative Bacilli
- ClinicalTrials.gov ID
- NCT07612605
- Acronym / sponsor ID
- 2025ZD05493-3
- Conditions
- Pneumonia
- Keywords
- bacteriophage, Yiqi Huoxue Jiedu Formula, drug-resistant bacteria, Pneumonia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 May 2026 (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.
Through a prospective randomized controlled trial, we systematically evaluate the effects of Yiqi Huoxue Jiedu Formula combined with bacteriophage therapy on the bacterial clearance rate, disease improvement rate and mortality rate in patients with severe pneumonia caused by drug-resistant bacteria, so as to clarify its clinical transformation value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YHDF Placebo + Bacteriophage Placebo Group | Placebo comparator | Drug: YHDF placebo, Drug: Bacteriophage Placebo7-14 days treatment with YHDF placebo, 7-14 days treatment with phage placebo |
| YHDF Placebo + Bacteriophage Group | Active comparator | Drug: YHDF placebo, Drug: Bacteriophage7-14 days treatment with YHDF placebo, 7-14 days treatment with phage placebo |
| YHDF Drug + Bacteriophage Placebo Group | Active comparator | Drug: Bacteriophage Placebo, Drug: YHDF Drug7-14 days treatment with YHDF, 7-14 days treatment with phage placebo |
| YHDF Drug + Bacteriophage Group | Active comparator | Drug: YHDF Drug, Drug: Bacteriophage7-14 days treatment with YHDF, 7-14 days treatment with phage |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the diagnostic criteria for severe pneumonia caused by drug-resistant Gram-negative bacilli and conform to the TCM syndrome differentiation of Qi deficiency, toxin accumulation and blood stasis syndrome;
- Patients confirmed by rapid on-site microbiological evaluation (M-ROSE), clinical microbial culture and drug susceptibility testing (based on the drug susceptibility test results of our hospital or other Grade A tertiary hospitals) to be infected with multidrug-resistant Klebsiella pneumoniae, Acinetobacter baumannii or Pseudomonas aeruginosa;
- Aged 18 to 85 years old;
- Patients or their family members agree to cooperate with the collection of upper and lower respiratory tract specimens, consent to bronchoscopy plus bronchoalveolar lavage, and agree to receive nebulized inhalation of bacteriophage therapy;
- Patients or their family members have fully read, understood and signed the informed consent form.
Key exclusion criteria (8 listed)
- Women who are pregnant or lactating;
- Patients with immunodeficiency;
- Patients receiving immunosuppressive therapy or suffering from immunodeficiency diseases;
- Patients who have received mechanical ventilation for more than 60 days prior to enrollment;
- Patients with active pulmonary tuberculosis, lung abscess, or Grade D chronic obstructive pulmonary disease (COPD);
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 |
|---|---|---|
| YHDF placebo7-14 days treatment with YHDF placebo | Drug | YHDF Placebo + Bacteriophage Group, YHDF Placebo + Bacteriophage Placebo Group |
| Bacteriophage Placebo7-14 days treatment with bacteriophage placebo | Drug | YHDF Drug + Bacteriophage Placebo Group, YHDF Placebo + Bacteriophage Placebo Group |
| YHDF Drug7-14 days treatment with YHDF | Drug | YHDF Drug + Bacteriophage Group, YHDF Drug + Bacteriophage Placebo Group |
| Bacteriophage7-14 days treatment with bacteriophage | Drug | YHDF Drug + Bacteriophage Group, YHDF Placebo + Bacteriophage Group |
Primary outcome
Clearance rate of drug-resistant bacteria
Time frame: 14 days
2 secondary outcomes
Time to clinical improvement
Time frame: 7 days
All-cause mortality
Time frame: 28 days
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 29 May 2026.
- Individual participant dataSharing planned: No
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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.
Lixin Xie study director
College of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing YHDF Drug and Bacteriophage in people with Pneumonia, run by Chinese PLA General Hospital at 4 sites 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianqiao Xu (8617310692712, 774690118@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance rate of drug-resistant bacteria (time frame: 14 days). 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 29 May 2026.