Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
Recruiting now · Not applicable
Conditions studied: Klebsiella Pneumoniae Pneumonia
In brief
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.
Key facts
- Study ID
- NCT06641778
- Run by
- luxia Kong
- People needed
- 100
- Starts
- 2024-12-03
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-12-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The central Hospital of Wuhan — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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