Drug-resistance bacterial infectious disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-90-year-old patients with multi-drug resistant bacteria infection; 2. The pathogenic bacteria should meet one of the following conditions: 1) Pathogens are fully resistant to antibiotics; 2) Pathogens are resistant to key antibiotics (see the 12 categories of super bacteria* [1] released by WHO in 2017); 3) The pathogen is sensitive to key antibiotics in vitro, but the antibiotic treatment is ineffective or the effect is not obvious (the effect is not obvious is defined as repeated infection of the same kind of drug-resistant pathogen or the patient has antibiotic dependence and cannot stop the drug for 2 months or more); 4) Pathogens have limited use of key sensitive antibiotics (such as organ toxicity or patients allergic to this antibiotic); 3. At least one kind of lytic phage can be screened; 4. It can be administered by spraying, external application, aerosol inhalation, perfusion, local injection or diversion tube through the infected area; 5. Subjects and family members (or guardians) fully read, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Bacterial infection can be effectively controlled by antibiotic treatment; 2. There is no other route of administration except intravenous injection; 3. Patients judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of target strain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of clinical symptoms; | — |
Countries
China
Contacts
Shanghai Public Health Clinical Center