Fecal microbiota transplantation for treating drug-resistant pneumonia

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

This study is testing if adding a fecal transplant to regular antibiotic treatment can help people with drug-resistant pneumonia feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wuhan Central Hospital (other)
• Drugs / interventions: rituximab, doxorubicin
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06641778 on ClinicalTrials.gov

What this trial studies

This study investigates the use of fecal microbiota transplantation (FMT) as a treatment for patients suffering from multidrug-resistant Klebsiella pneumoniae pneumonia. Participants are randomly assigned to receive either conventional antibiotic treatment alone or conventional treatment combined with FMT. The study aims to compare clinical symptoms, inflammatory and immune responses, and changes in intestinal and respiratory microbiomes between the two groups. By exploring the therapeutic potential of FMT, the study seeks to address the challenges posed by antibiotic resistance in pneumonia cases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 diagnosed with community-acquired or hospital-acquired pneumonia caused by multidrug-resistant Klebsiella pneumoniae.

Not a fit: Patients with severe pulmonary dysfunction, persistent bronchial asthma, or significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with multidrug-resistant pneumonia.

How similar studies have performed: While fecal microbiota transplantation has shown promise in treating various conditions, its application for multidrug-resistant pneumonia is relatively novel and untested.

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.

Where this trial is running

Wuhan, Hubei

• The central Hospital of Wuhan — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Luxia Kong, master

Conditions: Klebsiella Pneumoniae Pneumonia, Fecal Microbiota Transplantation, Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia