| CTRI Number |
CTRI/2025/10/096532 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of CYP2c19 genetic polymorphisms on Voriconazole therapy in immunocompromised patients and using TDM to personalize therapy |
|
Scientific Title of Study
|
"Personalizing Antifungal Therapy: Impact of CYP2C19 Genetic Variants on Voriconazole Pharmacokinetics in Indian Adults." |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPT/VPS/01 Version:01 Date 03/07/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gatadi K Sumedh |
| Designation |
Senior Resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology, Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500083
India |
| Phone |
9985978994 |
| Fax |
|
| Email |
sumedh.gatadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C Prabhakar Reddy |
| Designation |
Addl Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology, Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500083
India |
| Phone |
7416512888 |
| Fax |
|
| Email |
cptnims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C Prabhakar Reddy |
| Designation |
Addl Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology, Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500083
India |
| Phone |
7416512888 |
| Fax |
|
| Email |
cptnims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Gatadi K Sumedh |
| Address |
Department of Clinical Pharmacology,NIMS |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gatadi K Sumedh |
Nizams Institute Of Medical Sciences |
Dept Of Clinical Pharmacology,2nd floor,Old Building,NIMS, Punjagutta
Hyderabad
TELANGANA |
9985978994
sumedh.gatadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B440||Invasive pulmonary aspergillosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Proportion of patients achieving therapeutic voriconazole trough concentrations across different CYP2C19 genotype categories (poor, intermediate, extensive, ultra-rapid metabolizers) |
Trough sample will be collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
Single trough level |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study primarily aims to evaluate the association between CYP2C19 genetic
polymorphisms and steady-state trough concentrations of voriconazole
in Indian adult patients. Given voriconazole’s nonlinear pharmacokinetics and
metabolism primarily via CYP2C19, genetic variations significantly influence
drug exposure, potentially leading to subtherapeutic or toxic levels. By
categorizing patients into metabolizer phenotypes (poor, intermediate,
extensive, ultra-rapid) based on genotyping, the study seeks to determine how
these variants affect plasma drug levels. Understanding this relationship will
support genotype-guided dosing and enhance therapeutic precision, especially in
immunocompromised patients where accurate drug exposure is critical for
successful antifungal therapy. |