Health Condition 1: B440- Invasive pulmonary aspergillosis
Conditions
Interventions
Intervention1: TDM BASED DOSE OPTIMIZATION: CHECKING CONCENTRATION OF VORICONAZOLE AND DOSE MODIFICATION IF ANY
Intervention2: NA AS IT IS AN OBSERVATIONAL STUDY: NA
Control Intervention1: NIL: NIL
Sponsors
DR SAJITHA V
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with invasive aspergillosis based on clinical, radiological, and microbiological criteria. 2. Patients prescribed voriconazole therapy for treatment. 3.Patients willing to participate and provide informed consent (or consent from guardians for minors). 4. Patients undergoing Therapeutic Drug Monitoring for voriconazole.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to voriconazole. 2. Patients on concomitant medications that strongly induce or inhibit CYP2C19, affecting voriconazole metabolism. 3. Patients with severe hepatic impairment (Child-Pugh C) where voriconazole dose adjustments are not feasible. 4. Patients who do not consent to participate in the study. 5. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of IA treatment with TDM-guided voriconazole dose optimization.Timepoint: voriconazole drug levels monitored after 5 to 7 days of therapy, assessment of therapeutic index is done and dose optimised accordingly. Success rate of IA treatment with TDM-guided voriconazole dose optimization done. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in toxicity-related treatment discontinuation. 2. Overall survival & mortality rate at study completion. Timepoint: Overall survival & mortality rate at study completion at 1 year. | — |
Countries
India
Contacts
Public ContactDR SAJITHA V
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
Outcome results
None listed