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

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.

Study Overview

• Status: Recruiting
• Conditions: Klebsiella Pneumoniae Pneumonia
• Intervention / Treatment: Other: Fecal Microbiota Transplantation

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luxia Kong, master; Phone Number: 17671460541; Email: 510229519@qq.com
• Study Contact Backup: Name: Shuang Geng, doctor; Phone Number: 027-82223802

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430014
      • Recruiting
      • The Central Hospital of Wuhan
      • Contact: Luxia Kong; Phone Number: 17671460541; Email: 510229519@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; This group of patients received conventional antibiotic therapy and fecal microbiota transplantation.	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
No Intervention: control group; Patients in this group were treated with conventional antibiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days MDR-KP turns negative	The number of days that multidrug-resistant Klebsiella pneumoniae turned negative after treatment	one month
Length of hospital stay	Total length of stay from admission to discharge or death	one month
mortality rate	The ratio of death cases to the total number of patients	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of fever	The incidence of fever in patients was included	one month
The incidence of cough	The incidence of cough in patients was included	one month
The incidence of phlegm	The incidence of phlegm in patients was included	one month
The incidence of chest pain assessed by VAS	The incidence of chest pain in patients was included	one month

Collaborators and Investigators

• Sponsor: luxia Kong
• Investigators: Study Director: Shuang Geng, Wuhan Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 3, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Enterobacteriaceae Infections; Pneumonia; Klebsiella Infections
• Other Study ID Numbers: LXKong

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No