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A Multicenter, Prospective, Observational Study Evaluating the Efficacy and Safety of Conventional Treatment Regimens for Multidrug-Resistant Bacterial Infections in Liver Transplant Recipients

A Multicenter, Prospective, Observational Study Evaluating the Efficacy and Safety of Conventional Treatment Regimens for Multidrug-Resistant Bacterial Infections in Liver Transplant Recipients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098612
Enrollment
Unknown
Registered
2025-03-11
Start date
2025-03-17
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multidrug - resistant infections after liver transplantation

Interventions

Exposure group:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 years or above; 2.Patients who have undergone allogeneic liver transplantation and are receiving treatment with at least one immunosuppressive agent (Definition of immunosuppressive agents: glucocorticoids, calcineurin inhibitors, antimetabolites, mammalian target of rapamycin inhibitors, etc.). 3.Known or highly suspected to have multi - drug - resistant pathogen (MDR) infection. The MDR criteria conform to the definition in 'Chinese Expert Consensus on the Prevention and Control of Healthcare - associated Infections Caused by Multi - drug - resistant Organisms'. Multi - drug - resistant organisms (MDR) refer to bacteria that are simultaneously resistant to three or more categories of commonly used antimicrobial agents to which they are usually susceptible. 4.Having applied the initially selected or replacement anti - infectious treatment regimen for at least 3 days. 5.The clinical outcomes of the cases are complete, and the data can meet the evaluation of treatment outcomes (clinical outcomes, microbiological outcomes, and safety evaluation). 6.Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.There are obvious deficiencies in the selection or use of the treatment regimen in clinical evaluation. For example, when there are drugs sensitive in the drug sensitivity test, a single - drug regimen that is clearly shown to be resistant in the drug sensitivity test is selected. 2.The researchers believe that there are any interfering factors that may affect the test results.

Design outcomes

Primary

MeasureTime frame
Comprehensive efficacy;Clinical effective rate;Microbial clearance rate;

Secondary

MeasureTime frame
Clinical adverse events;

Countries

China

Contacts

Public ContactZhengxin Wang

Huashan Hospital, Fudan University

wangzhengxin@huashan.org.cn+86 21 52887174

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026