Pulmonary infection
Conditions
Interventions
Experimental Group:Carrimycin tablets combined with polymyxin
Control Group:Polymyxin combined with other antibiotics
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The subject or legal representative has signed an informed consent form; 2. Aged 18-85 years, including boundary value; 3. Pulmonary infection caused by carbapenem-resistant gram-negative bacteria (HAP hospital-acquired pneumonia/VAP ventilator-associated pneumonia/HCAP health care associated pneumonia). For detailed diagnosis and exclusion criteria, see guidelines for the diagnosis and treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in China for adults, 2018 edition. The diagnosis criteria of carbapenem-resistant gram-negative bacteria are as follows (all the following conditions must be met before being included in the group): (1) Carbapenem resistant gram-negative bacteria culture positive; (2) Monitoring the proliferation time of carbapenem-resistant gram-negative bacteria under culture 2 mg/L and the MIC value of polymyxin B <= 2 mg/L; 5. Patients with normal gastrointestinal function or with an AGI score of I. Patients with an AGI score of II must be assessed by the investigator for good drug absorption; 6. It is convenient to take the medicine on time, to observe and adjust the dosage at any time and deal with the inpatients with possible adverse reactions.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to the study drug or the active ingredient (Carrimycin); 2. In the 72 hours before randomization, patients who have continuously received 36 hours of potentially effective antibiotic treatment for carbapenem-resistant gram-negative bacteria due to HAP/VAP/HCAP; 3. Patients with irreversible or dying conditions; 4. Patients who are on Extracorporeal Membrane Oxygenation (ECMO); 5. Shock patients whose hemodynamics are unstable and cannot be controlled by infusion and vasoactive drug therapy; 6. Patients with life-threatening hypoxemia, compensatory or permissive hypercapnia, and acidosis that have not been controlled; 7. Patients with bloodstream infection caused by CRO; 8. Combined with serious primary diseases that affect survival, including hematological diseases, hematological tumors, HIV, etc.; 9. Those who participated in the clinical trials of any drug or medical device within 1 month before the trial, or those who were within 5 half-lives of other trial drugs before screening; 10. Organ transplantation within 6 months before the trial; 11. Child-Pugh liver function rating is C; 12. Combined use of other antibiotics that inhibit protein synthesis, including but not limited to aminoglycosides, other macrolides, linezolid, chloramphenicol, and lincosamide; 13. Pregnant women, lactating women, subjects (including male subjects) have pregnancy plans (including sperm donation and egg donation plans) or are unable to take effective contraceptive measures in the next 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial clearance rate after 14 days;The number of cases enrolled within 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial clearance rate after 8 days;Leukocyte count;Leukocyte differential count;C reactive protein;Arterial blood gas;Procalcitonin;Chest radiograph;Body temperature stabilization time;The clinical success rate;Comprehensive curative effect recovery rate;The hypothetical clearance rate of microbiological efficacy; | — |
Countries
China
Contacts
Public ContactWu Jianfeng
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed