infection
Conditions
Interventions
Experimental group:Decolonization with oral antibiotics and probiotics
Control group:None
Sponsors
First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18-75 years; 2. Patients with end-stage liver disease who plan to undergo liver transplantation; 3. Two preoperative rectal swab tests or stool culture suggest CRE colonization; 4. Stable vital signs: no need for vasoactive drugs to maintain blood pressure; under resting state, oxygen saturation > 92%; 5. Be able to understand and sign the informed consent; 6. Patients of childbearing age agree to take effective contraceptive measures during the study period.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. Patients with known CRE infection; 3. Symptoms of intestinal infection such as fever and diarrhea within 2 weeks; 4. Patients who have received or are receiving antibiotics including carbapenems, aminoglycosides, tigecycline, polymyxin, fosfomycin and ceftazidime avibactam within 2 weeks; 5. Patients with hepatic encephalopathy grade III-IV; 6. The patient needs urgent liver transplantation and cannot complete 7-14 days of decolonization treatment; 7. Allergic to gentamicin, polymyxin, probiotics, or unable to take oral drugs; 8. Patients with colon or jejunostomy; 9. Active gastrointestinal bleeding; 10. Participate in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CRE infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Incidence of all infections;Sensitivity to gentamicin, polymyxin, tigecycline (MIC);Acute rejection occurs with in 30 days after transplantation;The success rate and recurrence rate of decolonization;Emergence of new drug resistance in colonized CRE;Intestinal colonization by other resistant bacteria (VRE, ESBL, etc.); | — |
Countries
China
Contacts
Public ContactZhang Wei
First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed