Complicated Intra-Abdominal Infection (cIAI)Specific
Conditions
Interventions
Imipenem-cilastatin-relebactam group:None
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years; 2.Patients who are admitted and receive treatment within the enrollment time window; 3.Patients presenting to our hospital diagnosed with complicated intra-abdominal infection. 4.Initiate antimicrobial therapy within 24 hours of diagnosis. 5.Meets criteria for high-risk CRE infection; 6.For patients initially receiving empirical therapy with imipenem-cilastatin or standard of care (SOC), with an anticipated or actual treatment duration of >=96 hours; 7.Voluntarily participate in the study and sign the informed consent form. If a subject is unable to read or sign the informed consent form due to incapacity or other reasons, the informed consent process shall be conducted by their legal guardian, who will sign on the subject’s behalf. If a subject is unable to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed by an impartial witness, who will also sign the form. 8.The case data are sufficient for outcome assessment.
Exclusion criteria
Exclusion criteria: 1.Patients who have obtained definitive pathogen susceptibility results before initial empirical therapy and have selected a targeted antimicrobial regimen accordingly (i.e., non-empirical therapy); 2.The temporal relationship between the first effective source control measure (e.g., puncture drainage, surgical procedure) and the first administration of the study drug cannot be clearly determined; 3.Patients with an APACHE II score greater than 30; 4.Patients with severe hepatic impairment (Child-Pugh class C); 5.Presence of end-stage renal disease at enrollment (eGFR <15 mL/min/1.73 m^2 or receiving dialysis); 6.Subjects whose subsequent pathogen culture/susceptibility testing confirms that the causative pathogen is not susceptible to imipenem-cilastatin-relebactam: After enrollment, sensitivity analyses will be performed as pre-specified (ITT and mMITT), and the primary analysis may either exclude these subjects or reassign them to the non-susceptible subgroup; 7.Vulnerable populations other than critically ill patients, the elderly, or illiterate individuals, including those with mental illness, cognitive impairment, pregnant and lactating women, etc; 8.Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of side effects;Bacteria clearance rate; | — |
Countries
China
Contacts
Public ContactGuo Feng
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed