Complicated intra-abdominal infections
Conditions
Interventions
Eravacycline group:Intravenous eravacycline
Tigecycline group:Intravenous tigecycline
Sponsors
Ansteel Group General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. ICU inpatients with cIAI; 2. 18 to 85 years old, without sexual restrictions; 3. Transfer to ICU after surgery with confirmation (with pus in the abdominal cavity) of an intra-abdominal infection associated with peritonitis; 4. Confirm infection through surgical intervention within 24 hours after entering the ICU: evidence of systemic inflammatory response, consistent with physical examination results of intra-abdominal infection, and supportive imaging findings of intra-abdominal infection; 5. Patients with infected lesions that have been effectively removed, drained, or do not require surgical intervention; 6. Patients or their families will fully understand the purpose and significance of the experiment, voluntarily participate and sign an informed consent form containing contact information.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to any excipients contained in eravacycline, tigecycline, tetracycline, or study drug formulations; 2. Other intraperitoneal lesions that are unlikely to have infectious primary causes, such as inflammatory bowel disease, liver abscess, abdominal wall abscess, intestinal obstruction without perforation, or ischemic intestinal perforation; 3. The patient is suspected to have an intra-abdominal infection caused by fungi, parasites, viruses, or pulmonary tuberculosis; 4. Exclusion criteria related to antibiotics: a. Within 72 hours before randomization, those who were treated with effective antibiotics for more than 24 hours [however, those who had a clear baseline pathogen and failed treatment after at least 72 hours of antibiotic treatment could be enrolled], or b. CIAI is known to be caused by pathogens resistant to one of the investigational drugs, or c. Received research medication or its equivalent to treat the current infection, or d. In addition to research drugs, it is also necessary to combine non-research antibacterial drugs. 5. It is expected to require systemic antibiotics lasting for more than 14 days; 6. Creatinine clearance rate = 30mL/min; 7. There is obvious liver disease, liver function damage (Child-Pugh C grade), or possible signs of liver disease and/or abnormal laboratory test values: a. ALT or AST>5xULN; b. Total bilirubin>3xULN; c. AST or ALT>3xULN, and total bilirubin>2xULN; 8. Patients with congenital or acquired immunodeficiency diseases, or those who have received organ transplantation within one year before enrollment, or those who have received immunosuppressive drug treatment within 30 days before enrollment; 9. Within 7 days before randomization or expected during the study treatment period, use strong CYP3A inducers such as phenytoin sodium, rifampicin, and carbamazepine; 10. Systemic malignant tumors that require chemotherapy, immunotherapy, radiation therapy, or anti-tumor treatment within the past 3 months before TOC visits; 11. Pregnant women, lactating women, or those who have a birth plan within 2 weeks after the end of the study; 12. Participate in clinical trials of other drugs or medical devices within one month before screening; 13. The study period in which patients are expected to survive or have a treatment intention of less than 6 to 8 weeks; 14. Researchers have determined that patients do not meet the criteria for inclusion in clinical trials for various reasons, such as those with concomitant cerebral hernia, acute myocardial infarction, pulmonary embolism, or those receiving ECMO treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day all-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy;Microbiological efficacy; | — |
Countries
China
Contacts
Public ContactDianhong Zhang
Ansteel Group General Hospital
Outcome results
None listed