Clinical trial NCT06641778: Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
Official title: Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Klebsiella Pneumoniae Pneumonia
Keywords: Fecal Microbiota Transplantation
Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
Lead sponsor: Wuhan Central Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Number of days MDR-KP turns negative
timeFrame: one month
measure: Length of hospital stay
timeFrame: one month
measure: mortality rate
timeFrame: one month
Secondary outcomes:
measure: The Incidence of fever
timeFrame: one month
measure: The incidence of cough
timeFrame: one month
measure: The incidence of phlegm
timeFrame: one month
measure: The incidence of chest pain assessed by VAS
timeFrame: one month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: The central Hospital of Wuhan
state: Hubei
Study officials:
affiliation: Wuhan Central Hospital
name: Shuang Geng
role: STUDY_DIRECTOR
References: