PneumoniaEarly Phase 1NCT07338123
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
A Early Phase 1 study testing YHDF Drug and Bacteriophage in people with Pneumonia, run by Chinese PLA General Hospital.
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 years and older
- 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
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Aug 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 years and older
- 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.
About this study
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 Drug, YHDF Placebo, Bacteriophage, Bacteriophage Placebo
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHDF DrugDrug
7-day treatment with YHDF Drug
YHDF PlaceboDrug
7-day treatment with YHDF placebo
BacteriophageDrug
7-14-day treatment with phage
Bacteriophage PlaceboDrug
7-14-day treatment with phage placebo
| Study group | Role | What they receive |
|---|---|---|
| YHDF Placebo + Bacteriophage Placebo Group | Placebo comparator | Not described Receives: Drug: YHDF Placebo; Drug: Bacteriophage Placebo |
| YHDF Placebo + Bacteriophage Group | Placebo comparator | Not described Receives: Drug: YHDF Placebo; Drug: Bacteriophage |
| YHDF Drug + Bacteriophage Placebo Group | Placebo comparator | Not described Receives: Drug: YHDF Drug; Drug: Bacteriophage Placebo |
| YHDF Drug + Bacteriophage Group | Experimental | Not described 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 posted13 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Aug 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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338123
- Sponsor's protocol ID
- 2025ZD0549303
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 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
- NCT07338123
- Acronym / sponsor ID
- 2025ZD0549303
- Conditions
- Pneumonia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 13 Jan 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
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YHDF Placebo + Bacteriophage Placebo Group | Placebo comparator | Drug: YHDF Placebo, Drug: Bacteriophage Placebo |
| YHDF Placebo + Bacteriophage Group | Placebo comparator | Drug: YHDF Placebo, Drug: Bacteriophage |
| YHDF Drug + Bacteriophage Placebo Group | Placebo comparator | Drug: YHDF Drug, Drug: Bacteriophage Placebo |
| YHDF Drug + Bacteriophage Group | Experimental | Drug: YHDF Drug, Drug: Bacteriophage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 (1 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); 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.
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 Drug7-day treatment with YHDF Drug | Drug | YHDF Drug + Bacteriophage Group, YHDF Drug + Bacteriophage Placebo Group |
| YHDF Placebo7-day treatment with YHDF placebo | Drug | YHDF Placebo + Bacteriophage Group, YHDF Placebo + Bacteriophage Placebo Group |
| Bacteriophage7-14-day treatment with phage | Drug | YHDF Drug + Bacteriophage Group, YHDF Placebo + Bacteriophage Group |
| Bacteriophage Placebo7-14-day treatment with phage placebo | Drug | YHDF Drug + Bacteriophage Placebo Group, YHDF Placebo + Bacteriophage Placebo 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 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
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.
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 1 inclusion and 1 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 13 Jan 2026.