Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal Microbiota Transplantation.
- Who it may be relevant to
- Registry conditions: Klebsiella Pneumoniae Pneumonia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Fecal Microbiota Transplantation
Patients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group
Primary outcome measures
- Number of days MDR-KP turns negative [Time frame: one month]
- Length of hospital stay [Time frame: one month]
- mortality rate [Time frame: one month]
Secondary outcome measures (4)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The central Hospital of Wuhan — Wuhan
Identifiers
NCT: NCT06641778 · LXKong