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

NCT06641778 | Recruiting

• 1 other identifier: LXKong
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Klebsiella Pneumoniae Pneumonia

Keywords

Fecal Microbiota Transplantation; Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• The Incidence of fever

  one month

• The incidence of cough

  one month

• The incidence of phlegm

  one month

• The incidence of chest pain assessed by VAS

  one month

Study Arms (2)

experimental group

EXPERIMENTAL

This group of patients received conventional antibiotic therapy and fecal microbiota transplantation.

Other: Fecal Microbiota Transplantation

control group

NO INTERVENTION

Patients in this group were treated with conventional antibiotics.

Interventions

Fecal Microbiota Transplantation OTHER

Patients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• luxia Kong: lead

Study Sites (1)

The central Hospital of Wuhan

Wuhan, Hubei, 430014, China

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Shuang Geng

  Wuhan Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Luxia Kong, master

CONTACT

17671460541; 510229519@qq.com

Shuang Geng, doctor

CONTACT

027-82223802

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 15, 2024
• Study Start: December 3, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

CN (1)