Status:
RECRUITING
FMT for Lung and Associated-organ Rescue Efficacy in Pulmonary Infection With MDROs
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Lung Infection
Microbial Colonization
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Currently, lung infections caused by multidrug-resistant organisms (MDROs) represent a significant global health burden. In the intensive care unit (ICU), the administration of antibiotics, opioids, p...
Eligibility Criteria
Inclusion
- The initial step involves characterizing alterations in the pulmonary and intestinal microbiota among ICU patients with pathogen-associated infections, including multidrug-resistant organisms (MDROs), and examining the associations between these microbial changes.
- Age ranging from 18 to 70 years old;
- Gender and ethnicity are not restricted;
- Informed consent obtained.
Exclusion
- Airway antibiotics (administered via nebulization or intravenous infusion) have been utilized since the current hospitalization;
- Pulmonary infection caused by non-bacterial pathogens, such as viruses, fungi, or atypical organisms;
- Infections located outside the pulmonary system, including those in the bloodstream, abdominal cavity, or urinary tract;
- Respiratory failure secondary to non-pulmonary infections, such as cardiogenic factors or sepsis-like syndromes;
- Chronic pulmonary conditions, including chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, and pulmonary interstitial fibrosis;
- Chronic gastrointestinal disorders, such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, and non-alcoholic fatty liver disease (NAFLD);
- Recent surgical procedures involving the abdomen or lungs (within 14 days prior to admission);
- Pregnant or lactating individuals；
- Subjects who participated in other clinical studies as trial participants at the time of enrollment or within 3 months prior to enrollment；
- Lack of a signed written informed consent form.
- Further trial will be conducted to investigate the effect and safety of FMT on the recovery of pulmonary microecological imbalance in critically ill patients, and to evaluate its impact on the length of stay in the ICU, ICU mortality, in-hospital mortality, and 28-day mortality, etc.
- Inclusion Criteria:
- Age 18-70 years, regardless of gender or ethnicity;
- ICU admission ≥24 hours;
- Expected ICU stay ≥7 days;
- Mechanically ventilated patients with confirmed pulmonary MDRO infection prior to enrollment. Target MDRO has available narrow-spectrum antibiotics; if the pathogen is pan-resistant (e.g., pan-drug-resistant Acinetobacter baumannii) and treatment relies solely on polymyxins or other limited options, exclusion is required. The attending physician must confirm that short-term discontinuation of broad-spectrum antibiotics is safe;
- Written informed consent provided.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06970262
Start Date
May 20 2025
End Date
December 31 2026
Last Update
January 9 2026
Active Locations (1)
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1
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China