Posaconazole-Associated Adverse Reactions
Conditions
Interventions
Posaconazole Group:NA
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Hospitalized in our institution between October 1, 2021, and December 31, 2024. 2. Received posaconazole therapy (formulations included oral tablets, oral suspension, or intravenous injection) for a duration of >=5 days. 3. Had at least one recorded therapeutic drug monitoring (TDM) of posaconazole plasma concentration during the treatment course. 4.Possessed complete clinical data and follow-up records, including at a minimum: Baseline liver and renal function tests prior to initiation of posaconazole. Records of adverse reactions during the treatment period.
Exclusion criteria
Exclusion criteria: 1. Presence of severe hepatic or renal impairment, defined as: Liver function classified as Child-Pugh grade C within one week prior to medication initiation, or Renal function with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m². 2. Concomitant use of drugs that significantly interact with posaconazole metabolism (e.g., strong CYP3A4 inducers like rifampin, phenytoin). 3. A documented history of hypersensitivity to posaconazole or other triazole antifungal agents (such as fluconazole, itraconazole). 4. Subjects with a significant amount of missing data, defined as a missing rate exceeding 30% for key variables (such as drug concentration or adverse reaction records). 5. Only the first hospitalization is included for patients with multiple admissions for the same condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Posaconazole-Associated Adverse Reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Types of adverse reactions;Time of occurrence of adverse reactions;Duration of adverse reactions; | — |
Countries
China
Contacts
Public ContactMing Chen
Shanghai General Hospital
Outcome results
None listed