carbapenem-resistant Enterobacteriaceae related infections
Conditions
Interventions
Phage Therapy Group:Phage
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.1 Patients aged 18-70 years with carbapenem-resistant Enterobacteriaceae infections (catheter-associated urinary tract infection, lung infection); 1.2 The pathogen causing the patient’s infection should meet one of the following criteria: 1) The pathogen is resistant/pan-resistant to carbapenem antibiotics; 2) The pathogen is in vitro susceptible to key antibiotics (colistin, ceftazidime-avibactam, tigecycline) but treatment with these antibiotics is ineffective or not obvious (ineffective is defined as the same resistant pathogen or the patient develops antibiotic dependence and cannot be discontinued for more than one year); 3) The patient’s use of key antibiotics (colistin, ceftazidime-avibactam, tigecycline) is limited (patients with organ dysfunction or allergic to these antibiotics); 1.3 At least one phage that can lyse the resistant bacteria can be screened; 1.4 The drug can be administered by nebulization, infusion or catheter; 1.5 The subject and family members (or guardian) have fully read, understood and signed the informed consent form, and are highly compliant. All the above criteria must be met to be eligible for inclusion.
Exclusion criteria
Exclusion criteria: 1) No effective phage was matched. 2) No feasible phage administration route is available or contraindications to the administration route (nebulization, bronchoscopic lung lavage, bladder irrigation or catheter administration). 3) The patient refuses to receive phage therapy, or the patient is unable to sign informed consent due to consciousness disorder, mental illness, dementia, etc., and their legal representative does not agree to receive phage therapy. 4) If the following conditions occur, phage therapy should not be performed, unless clinical evaluation determines that the patient has no other feasible antibacterial treatment options other than phage therapy: unstable vital signs (temperature, heart rate, blood pressure, respiration); progressive tumors; severe immune system disorders; concurrent renal insufficiency (eGFR<30 ml/min/1.73m2), or patients undergoing CRRT, hemodialysis, or peritoneal dialysis. 5) Concomitant severe liver disease: decompensated cirrhosis, liver failure, Child-Pugh score grade C, etc. 6) Concomitant hematologic diseases: severe anemia (HGB<60g/L), thrombocytopenia (<50 × 109/L), granulocytopenia, leukemia, hemophagocytic syndrome, coagulopathy. 7) Patients with severe heart failure (heart function class III-IV). 8) Patients with sepsis, peritonitis, pleuritis and other systemic infections. 9) Patients with AIDS, organ transplantation, long-term use of hormones or immunosuppressants. 10) Patients with poor compliance. 11) Known allergy to phage products. 12) Pregnant or lactating women. 13) Participating in another clinical trial within 3 months prior to this study or currently participating in another clinical trial. Meeting any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiome changes ; | — |
Countries
China
Contacts
Public ContactZhiyong Zong
West China Hospital, Sichuan University
Outcome results
None listed