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NCT Number: NCT06641778

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The central Hospital of Wuhan

Wuhan, Hubei, 430014, China

Location status: Recruiting

Location contact

Luxia Kong

CONTACT

[email protected]

17671460541

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Number of days MDR-KP turns negative

    Time frame: one month

    The number of days that multidrug-resistant Klebsiella pneumoniae turned negative after treatment

  2. Length of hospital stay

    Time frame: one month

    Total length of stay from admission to discharge or death

  3. mortality rate

    Time frame: one month

    The ratio of death cases to the total number of patients

Secondary outcomes

  1. The Incidence of fever

    Time frame: one month

    The incidence of fever in patients was included

  2. The incidence of cough

    Time frame: one month

    The incidence of cough in patients was included

  3. The incidence of phlegm

    Time frame: one month

    The incidence of phlegm in patients was included

  4. The incidence of chest pain assessed by VAS

    Time frame: one month

    The incidence of chest pain in patients was included

Study contacts

Contact information is provided by the study sponsor or research team.

Luxia Kong, master

CONTACT

[email protected]

17671460541

Shuang Geng, doctor

CONTACT

027-82223802

Sponsors and collaborators

Lead sponsor

luxia Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.