Klebsiella Pneumoniae PneumoniaNCT06641778
Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
A study testing Fecal Microbiota Transplantation in people with Klebsiella Pneumoniae Pneumonia, run by luxia Kong at 1 site in China.
Trial summary
Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Klebsiella Pneumoniae Pneumonia
- What is being tested?
- Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 30 Sep 2026
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75;
- Meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia;
- The etiological results of sputum or alveolar lavage fluid suggested MDR-KP infection;
- The patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform FMT treatment, and signed the informed consent.
Who cannot join
- Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy;
- Patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons;
- Those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; Subjects taking probiotics within 6 months;
- Enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons.
- Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk;
- Patients with malignant hypertension, recent myocardial infarction (≤6 months), severe arrhythmia, and cardiac insufficiency;
Show all 12Show fewer
- suffering from malignant tumor diseases, congenital or acquired immune deficiency diseases, other systemic inflammatory response diseases;
- Those who have recently been treated with high-risk immunosuppressive/cytotoxic drugs, such as rituximab, doxorubicin, or steroid hormones (20mg/d ponisone or higher) for more than 4 weeks;
- Severe immunosuppression: adult neutrophils <1 500/mm3, child neutrophils <1 000/mm3;
- Pregnancy or lactation;
- There is a mental disability or active mental illness that prevents informed consent;
- Conditions deemed unsuitable for study inclusion by other clinicians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shuang Geng, doctor contact
China1 site, 1 recruiting
- Recruiting
The central Hospital of Wuhan
Wuhan, Hubei, 430014
Luxia Kong, 17671460541, 510229519@qq.com
About this study
Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. This study explored the therapeutic value of fecal microbiota transplantation in patients with MDR-KP pneumonia.
Read the detailed description
Intervention study (controlled clinical study) : patients with multidrug-resistant Klebsiella pneumoniae pneumonia were randomly assigned to the experimental group (conventional antibiotic treatment + fecal microbiota transplantation) and the control group (conventional antibiotic treatment); The clinical symptoms, inflammatory indexes, immune indexes, intestinal microecology, respiratory microecology and antibiotic resistance gene changes were compared between the two groups.
- Conditions
- Klebsiella Pneumoniae Pneumonia
- Being tested
- Fecal Microbiota Transplantation
- Keywords
- Fecal Microbiota Transplantation, Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationOther
Patients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | This group of patients received conventional antibiotic therapy and fecal microbiota transplantation. Receives: Other: Fecal Microbiota Transplantation |
| control group | No intervention | Patients in this group were treated with conventional antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days MDR-KP turns negative
The number of days that multidrug-resistant Klebsiella pneumoniae turned negative after treatment
Measured: one month
Length of hospital stay
Total length of stay from admission to discharge or death
Measured: one month
mortality rate
The ratio of death cases to the total number of patients
Measured: one month
Secondary outcomes (4)
The Incidence of fever
The incidence of fever in patients was included
Measured: one month
The incidence of cough
The incidence of cough in patients was included
Measured: one month
The incidence of phlegm
The incidence of phlegm in patients was included
Measured: one month
The incidence of chest pain assessed by VAS
The incidence of chest pain in patients was included
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start3 Dec 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klebsiella Pneumoniae 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- luxia Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, luxia Kong, Wuhan Central Hospital
- Investigators
- Shuang Geng, Study director, Wuhan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641778
- Sponsor's protocol ID
- LXKong
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
- ClinicalTrials.gov ID
- NCT06641778
- Acronym / sponsor ID
- LXKong
- Conditions
- Klebsiella Pneumoniae Pneumonia
- Keywords
- Fecal Microbiota Transplantation, Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- luxia KongUniversity, hospital or other
- Study start
- 3 Dec 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. This study explored the therapeutic value of fecal microbiota transplantation in patients with MDR-KP pneumonia.
Detailed description
Intervention study (controlled clinical study) : patients with multidrug-resistant Klebsiella pneumoniae pneumonia were randomly assigned to the experimental group (conventional antibiotic treatment + fecal microbiota transplantation) and the control group (conventional antibiotic treatment); The clinical symptoms, inflammatory indexes, immune indexes, intestinal microecology, respiratory microecology and antibiotic resistance gene changes were compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Fecal Microbiota TransplantationThis group of patients received conventional antibiotic therapy and fecal microbiota transplantation. |
| control group | No intervention | –Patients in this group were treated with conventional antibiotics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75;
- Meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia;
- The etiological results of sputum or alveolar lavage fluid suggested MDR-KP infection;
- The patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform FMT treatment, and signed the informed consent.
Key exclusion criteria (12 listed)
- Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy;
- Patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons;
- Those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; Subjects taking probiotics within 6 months;
- Enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons.
- Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk;
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 |
|---|---|---|
| Fecal Microbiota TransplantationPatients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group | Other | experimental group |
Primary outcome
Number of days MDR-KP turns negative
Time frame: one month
The number of days that multidrug-resistant Klebsiella pneumoniae turned negative after treatment
Length of hospital stay
Time frame: one month
Total length of stay from admission to discharge or death
mortality rate
Time frame: one month
The ratio of death cases to the total number of patients
4 secondary outcomes
The Incidence of fever
Time frame: one month
The incidence of cough
Time frame: one month
The incidence of phlegm
Time frame: one month
The incidence of chest pain assessed by VAS
Time frame: one month
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 3 Dec 2024.
Related trials for Klebsiella Pneumoniae Pneumonia
Not yet recruitingPhase 3
An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"
P. Aeruginosa, Baumannii
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.
Shuang Geng, doctor contact
Shuang Geng study director
Wuhan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation in people with Klebsiella Pneumoniae Pneumonia, run by luxia Kong 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 4 inclusion and 12 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 3 Dec 2024. 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. 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 Luxia Kong, master (17671460541, 510229519@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days MDR-KP turns negative (time frame: one month). The study lists 3 primary outcomes in all. 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 3 Dec 2024.