| CTRI Number |
CTRI/2025/02/081462 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Effectiveness of Posaconazole 300 mg in Patients with Weak Immune Systems |
|
Scientific Title of Study
|
Evaluating effectiveness of 300 mg of Posaconazole in Immunocompromised patients: an observational study. |
| Trial Acronym |
POSA-TDM-01 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijaykumar Patil |
| Designation |
Consultant |
| Affiliation |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital |
| Address |
CPR Hospital, Room No. 07, Medicine Department, Dasara Chowk, Bhausingji road, Town Hall, Kolhapur
Kolhapur
MAHARASHTRA
416012
India |
| Phone |
9371877555 |
| Fax |
0231-2991534 |
| Email |
cromgoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director |
| Affiliation |
CROM Clinical Research & Medical Tourism Pvt. Ltd. |
| Address |
In front of AYUSH cell, MOPA International Airport Flyover junction, NH-17, Goa-Mumbai Highway, Dhargal, Oshalbag
North Goa
GOA
403513
India |
| Phone |
9158592177 |
| Fax |
0231-2991534 |
| Email |
clinicalresearchgoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director |
| Affiliation |
CROM Clinical Research & Medical Tourism Pvt. Ltd. |
| Address |
In front of AYUSH cell, MOPA International Airport Flyover junction, NH-17, Goa-Mumbai Highway, Dhargal, Oshalbag
North Goa
GOA
403513
India |
| Phone |
9158592177 |
| Fax |
0231-2991534 |
| Email |
clinicalresearchgoa@gmail.com |
|
|
Source of Monetary or Material Support
|
| CROM Clinical Research and Medical Tourism Pvt. Ltd. In front of AYUSH cell, MOPA International Airport Flyover junction, NH-17, Goa-Mumbai Highway, Dhargal, Oshalbag, Goa-403513 |
|
|
Primary Sponsor
|
| Name |
Bajaj Healthcare Limited |
| Address |
602-606, Bhoomi Velocity Infotech Park,
Above ICICI Bank, Road No. 23,
Wagle Industrial Estate,
Thane (w), 400604, Maharashtra, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B K Patil |
Prakash Institute of Medical Science and Research |
Clinical Research Department, Room No. 4, Islampur-Sangali, Islampur, Tal- Walwa
Sangli
MAHARASHTRA |
7969792777
prakashmc.research@gmail.com |
| Dr Vijaykumar Patil |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital |
Department of Medicine, CPR Hospital, Dasara Chowk, Bhausingji road, Town Hal
Kolhapur
MAHARASHTRA |
9371877555
0231-2991534
cromgoa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Prakash Medical College Institutional Ethics Committee |
Submittted/Under Review |
| Rajarshee Chhatrapati Shahu Maharaj Government Medical College, Chhatrapati Pramila Raje General Hospital Kolhapur Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunocompromised
patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients prescribed posaconazole 300 mg tablet and are required to undergo TDM for fungal prophylaxis or treatment in various clinical settings. |
|
| ExclusionCriteria |
| Details |
Patients with contraindications to posaconazole use.
Patients with incomplete medical records that impede thorough analysis.
Non-compliant patients who fail to adhere to the prescribed treatment regimen or timing.
Patients prescribed posaconazole for off-label indications not approved by regulatory authorities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the plasma concentrations of Posaconazole 300 mg using therapeutic
drug monitoring |
Day 1 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical outcomes, assess safety and adverse events, and analyze the correlation between TDM parameters and laboratory markers |
Day 1 and Day 7 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 protocol aims to investigate the efficacy and
safety of posaconazole 300 mg (Posatral 300mg) tablet across various
clinical indications in immunocompromised patients. By conducting a TDM for
posaconazole and evaluating the impact of routine laboratory measurements on
posaconazole concentrations, we seek to provide insights that can enhance the
routine clinical use of posaconazole and optimize patient care. |