Infections caused by carbapenem-resistant Acinetobacter baumannii or carbapenem-resistant Klebsiella pneumoniae or Pseudomonas maltophil
Conditions
Interventions
Elacycline group:None
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medicine University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients who are clinically diagnosed as eligible for treatment with elacycline must meet all of the following criteria in order to be selected: 1) = 18 years old. 2) Voluntarily participate in the study and sign the informed consent. If the subject is unable to read and/or sign the informed consent due to incapacity or other reasons, his/her guardian shall represent the informed process and sign the informed consent. 3)There are definite or advantageous pathogenic bacteria: carbapenem resistant Acinetobacter baumannii (CRAB), carbapenem resistant Klebsiella pneumoniae (CRKP), and Pseudomonas maltophilia cultured positive, and the combined drug sensitivity indicates that the combination regimen based on erythromycin is sensitive to this bacterium. If it is the result of sterile body fluid culture, it is a clear infection of the pathogenic bacteria; If it is a respiratory specimen, select dominant bacteria with a bacterial count of =+++and a proportion of over 80%. 4) Patients who have been treated with erythromycin for = 4 days.
Exclusion criteria
Exclusion criteria: 1) Intracranial infection and urinary tract infection. 2) Patients with no microbial culture results or lack of combined drug sensitivity results. 3) Patients who are not expected to survive beyond the study period. 4) The investigator believes that there might be any medical history, current condition, treatment, laboratory test abnormalities, or other conditions that could affect the outcome of the trial, interrupt the trial process (or the subject is unable to complete all required procedures and visits), or increase the subject's risk of receiving investigational drugs, as well as end-stage disease patients. 5) Patients with a history of allergic reactions to the tetracycline class or any of the adjuvants contained in the investigational drug formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbial clearance rate and comprehensive effective rate;Safety;28 day clinical effective rate, microbial clearance rate, comprehensive effective rate, and survival rate;Comparing the effectiveness of single drug sensitivity therapy and combination drug sensitivity therapy;Synergy rate of combination therapy with other antibiotics and elacycline; | — |
Countries
China
Contacts
Public ContactXing Xi
The First Affiliated Hospital of Zhejiang Chinese Medicine University
Outcome results
None listed