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Impact of CYP2c19 genetic polymorphisms on Voriconazole therapy in immunocompromised patients and using TDM to personalize therapy

Personalizing Antifungal Therapy: Impact of CYP2C19 Genetic Variants on Voriconazole Pharmacokinetics in Indian Adults. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096532
Enrollment
150
Registered
2025-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: B440- Invasive pulmonary aspergillosis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Dr Gatadi K Sumedh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Adult patients 18 years or above currently receiving voriconazole for 5 consecutive days for antifungal prophylaxis or treatment 2)Those willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1)Known poor compliance with voriconazole regimen. 2)If participated in other study in the past three months. 3)Participants on Phenytoin and Rifampicin will be excluded.

Design outcomes

Primary

MeasureTime frame
•Proportion of patients achieving therapeutic voriconazole trough concentrations across different CYP2C19 genotype categories (poor, intermediate, extensive, ultra-rapid metabolizers)Timepoint: Trough sample will be collected

Secondary

MeasureTime frame
1)Proportion of patients having adverse events 2)To evaluate the predictive performance of the Bayesian dosing model by assessing the accuracy & precision of model-predicted voriconazole plasma concentrations as compared to observed concentrations. 3)Percentage of patients achieving therapeutic trough concentrations (1to5.5 µg per mL) using model informed dosing. 4)Comparison of target attainment between Bayesian model guided dosing (simulation) & standard empirical dosing. Timepoint: Single trough level

Countries

India

Contacts

Public ContactC Prabhakar Reddy

Nizams Institute of Medical Sciences

cptnims@gmail.com7416512888

Outcome results

None listed

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