Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Number of days MDR-KP turns negative [Срок оценки: one month]
• Length of hospital stay [Срок оценки: one month]
• mortality rate [Срок оценки: one month]

Вторичные конечные точки (4)

• The Incidence of fever [Срок оценки: one month]
• The incidence of cough [Срок оценки: one month]
• The incidence of phlegm [Срок оценки: one month]
• The incidence of chest pain assessed by VAS [Срок оценки: one month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The central Hospital of Wuhan — Ухань

Идентификаторы

NCT: NCT06641778 · LXKong

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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