Intraperitoneal infection, bloodstream infection, pulmonary infection, urinary infection
Conditions
Interventions
Eravacycline group:Elacycline combine with other commonly used clinical fungicides (such as meropenem, polycolistin E, polymyxin B, levofloxacin, ceftazobactam, piperac
Tigacycline group:Tigacycline combine with other commonly used clinical fungicides (such as meropenem, polycolistin E, polymyxin B, levofloxacin, ceftazo
Sponsors
Shanghai tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The patient at least 18 years old on the date of signing the informed consent. 2.Willing and able to comply with all study evaluations and adhere to program schedules. 3.Diagnosis of complicated intra-abdominal infections, pulmonary infection, urinary tract infection, and bloodstream infection caused by CRKP requires intravenous antimicrobial therapy. 4.Axillary temperature >= 37°C or = 10,000 cells/mm^3 or <= 4,500 cells/mm^3 , and more than 15% of immature neutrophils (band neutrophils) observed in peripheral blood smear. 5.Agree to provide any bacterial isolates obtained from the current infection-related samples to the microbiology-related central laboratory for research-related microbiological testing, long-term storage and other future testing.
Exclusion criteria
Exclusion criteria: 1.The patient is less than 18 years old at the date of signing the informed consent. 2.Pregnant or lactating women. 3.The primary infection was not cleared. 4.Have a central nervous system infection (such as meningitis, brain abscess, ventriculoperitoneal shunt infection); 5.Have history of active liver disease or cirrhosis. 6.Combined with coagulation system disease or active bleeding. 7.Conditions associated with immunodeficiency or immunosuppression, including hematologic malignancies, bone marrow transplantation, known human immunodeficiency virus infection (CD4 count = 20mg prednisone/day or equivalent for > 4 weeks) or other immunosuppressive drugs. 8.Subjects were receiving either hemodialysis or peritoneal dialysis or microdialysis or continuous veno-venous hemofiltration or continuous veno-venous hemodialysis. 9.Expected lifetime < 3d or exit midway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the all-cause mortality rate in the eravacycline group with that in the tigecycline group, from the start of treatment to day 14, in the clinically assessable population.; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality in the clinically evaluable population was different between the two groups after initiation of treatment to day 28.;Differences in clinical outcomes in the clinically evaluable population were observed between the two groups at day 4 of treatment, end of treatment, cure test, and last follow-up visit.;Differences in safety and tolerability in the treatment of complex abdominal, pulmonary, urinary, and bloodstream infections caused by CRKP between the two groups.; | — |
Countries
China
Contacts
Public ContactYunlou Zhu
Shanghai tenth People's Hospital
Outcome results
None listed