Multidrug-Resistant Pseudomonas Aeruginosa (MDR-PA) infection.
Conditions
Interventions
standard-of-care anti-infective regimens group:None
Imipenem Cilastatin treatment group:None
Sponsors
Tongde Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adult inpatients aged >=18 years, regardless of gender; 2.Confirmed or clinically suspected MDR-PA infection diagnosed by attending physicians or higher-ranking physicians in accordance with the standardized diagnostic criteria of this study; 3.The investigator assesses that intravenous anti-MDR-PA antimicrobial therapy is required, with treatment regimens as follows: monotherapy with intravenous imipenem-cilastatin, or standard-of-care (SOC) anti-MDR-PA regimens recommended by clinical guidelines; 4.The patient or their legal guardian fully understands the study procedures and follow-up requirements, voluntarily signs a written informed consent form, and is able to complete the full 28-day follow-up.
Exclusion criteria
Exclusion criteria: 1.Documented medical history of type I immediate severe systemic hypersensitivity reactions (anaphylactic shock, laryngeal edema, severe hypotension) to any excipient or active ingredient of imipenem-cilastatin, or to all ß-lactam antibiotics. Common skin rashes and gastrointestinal intolerance are not grounds for exclusion; 2.The pathogenic PA strain responsible for the current infection is confirmed resistant to imipenem-cilastatin via antimicrobial susceptibility testing; 3.Diagnosed with refractory, poorly controlled active epilepsy with seizure episodes within the past 30 days, or a history of >= 2 generalized tonic-clonic seizures per year; 4.Missing core baseline study data: any irrecoverable core data including infection site, susceptibility test results, underlying diseases, organ function, and baseline inflammatory markers, which prevents confirmation of enrollment eligibility and assessment of primary efficacy endpoints; 5.On the day of enrollment, joint assessment by the attending physician and investigator determines the patient’s expected natural survival time < 48 hours; 6.Pregnant or breastfeeding women; women of childbearing age with a positive serum pregnancy test prior to enrollment shall be excluded directly; 7.Participation in other interventional clinical trials involving antimicrobial or anti-infective agents within the past 30 days; 8.Other medical conditions deemed unsuitable for study participation by the investigator after comprehensive evaluation of the patient’s underlying diseases, treatment adherence, medical follow-up conditions, concurrent critical complications, and other relevant factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End-of-Treatment (EOT) Clinical Success Rate;28-day All-Cause Mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Day 7 Clinical Success Rate;14-day All-Cause Mortality;Incidence of Drug-related adverse events;Microbiological Eradication Rate at End-of-Treatment (EOT);Composite clinical efficacy endpoint;Proportion of patients with CRP and PCT reduced to 50% within 48 hours; | — |
Countries
China
Contacts
Public ContactYuexing Tu
Tongde Hospital of Zhejiang Province
Outcome results
None listed