Drug-resistant bacterial infections
Conditions
Interventions
Phage-assisted therapy group:Nebulised inhalation of phage to assist in the treatment of drug-resistant bacterial infections
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-90 years with multi-drug resistant bacterial infections (based on the results of drug sensitivity testing in our hospital or an outside hospital of tertiary care or above); 2. Patients infected with pathogenic bacteria should meet one of the following conditions: (1) the pathogenic bacteria are fully resistant to antibiotics; (2) the pathogenic bacteria are resistant to key antibiotics (see WHO 2024 12 categories of superbugs *); (3) the pathogenic bacteria in vitro sensitive to key antibiotics but the antibiotic treatment is ineffective or ineffective (ineffective is defined as the same drug-resistant pathogenic bacteria repeated infections or the patient to develop antibiotic dependence can not stop for more than a year); (4) the pathogenic bacteria are limited to the use of key sensitive antibiotics (organ damage or patients allergic to this antibiotic); 3. At least one or more phage(s) that matches the drug-resistant bacteria can be screened; 4. Patients capable of being administered orally, topically, sprayed on infected foci, nebulised inhalation, instilled, injected locally, or through an introducer tube; 5. Subjects and family members (or guardians) fully read, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The condition is extremely serious and the ICU stay is less than 48 hours; 2. Non-drug resistant bacterial infections; 3. Patients with severe airway injury and bleeding; 4. Unable to receive inhalation therapy; 5. Presence of severe rheumatic and haematological diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome (death or not); | — |
Secondary
| Measure | Time frame |
|---|---|
| Body temperature;White cell count;C-reactive protein;Interleukin-6 (IL-6);Procalcitonin (PCT);Phage concentration in bronchoalveolar lavage fluid;Culture results of sputum and bronchoalveolar lavage fluid;Chest X-ray/CT scan;Ventilator parameters;Arterial blood gas analysis; | — |
Countries
China
Contacts
Public ContactLiu Xueyan
Shenzhen People's Hospital
Outcome results
None listed