Multidrug-resistant bacterial infections
Conditions
Interventions
experimental group:Phages for screening target bacteria are administered in vitro (by nebulization or local application) for 7 to 14 days.
Antibiotics administered intravenously for 14 to 18 days
control group:Normal saline are administered in vitro (by nebulization or local application) for 7 to 14 days.
Antibiotics administered intravenously for 14 to 18 days
Sponsors
Shenzhen Third people‘ Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with multidrug-resistant bacterial infections (based on antimicrobial susceptibility testing results from this hospital or an external tertiary or higher-level hospital) must be >= 18 years old. 2. The pathogens infecting patients must meet one of the following criteria: 1) The pathogen is pan-resistant to all antibiotics; 2) The pathogen is resistant to key antibiotics (see the 12 categories of superbugs published by the WHO in 2017); 3) The pathogen is sensitive in vitro to key antibiotics but is ineffective or ineffective with these antibiotics (ineffectiveness is defined as repeated infection with the target bacteria for two weeks or more that cannot be eliminated with continuous antibiotic therapy); 4) The pathogen has limited efficacy against key antibiotics (e.g., patients with organ toxicity or allergy to these antibiotics); 3. At least one lytic phage (a phage active against the target bacteria) must be screened for; 4. The drug must be administered via spraying, topical application, nebulized inhalation, infusion, local injection, or catheter at the site of infection; 5. The subject and family member (or guardian) must fully read, understand, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The bacterial infection can be effectively controlled by antibiotic treatment; 2. No effective phage has been identified; 3. No feasible route of phage administration is available, or there are contraindications to the route of administration (nebulized inhalation, catheter placement, instillation, wet compress); 4. The patient refuses phage therapy; 5. The patient is deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial clearance rate;Length of hospital stay; | — |
Countries
China
Contacts
Public ContactLu Hongzhou/ Zhou Yang
Shenzhen Third people‘ Hospital
Outcome results
None listed