| CTRI Number |
CTRI/2024/09/074381 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to determine safety and effectiveness of Liposomal Amphotericin B injection 50mg per vial (Lyophilized) TRASPOR(R), Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy. |
|
Scientific Title of Study
|
A Prospective, Multi-centre, Active Post-Marketing Surveillance Study of Liposomal Amphotericin B injection 50mg per vial (Lyophilized) TRASPOR (R) Manufactured by Emcure Pharmaceuticals LTD. in Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy in Real World Clinical Practice |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/22/010 Version 00 Dated 20.02.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketan Shah |
| Designation |
Principal Investigator |
| Affiliation |
Navneet Memorial Hospital |
| Address |
OPD-1, Ground Floor, Navneet Memorial Hospital
Opp. Sardar Patel Seva SUSHRUSHA" Samaj Hall, In the Lane, Opp. Tele. Exchange, Navrangpura, Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9825259052 |
| Fax |
|
| Email |
drketanshah013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Vala |
| Designation |
Associate Director |
| Affiliation |
Emcure Pharmaceuticals Limited |
| Address |
R and D Centre
Emcure Pharmaceuticals Limited
Uvarsad Square Sarkhej Gandhinagar Highway Adalaj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
7930640153 |
| Fax |
|
| Email |
neha.vala@emcure.com |
|
Details of Contact Person
Public Query
|
| Name |
Krunal Patel |
| Designation |
Manager Clinical Research Operations |
| Affiliation |
Emcure Pharmaceuticals Limited |
| Address |
R and D Centre
Emcure Pharmaceuticals Limited
Uvarsad Square Sarkhej Gandhinagar Highway Adalaj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
7930640138 |
| Fax |
|
| Email |
krunal.patel@emcure.com |
|
|
Source of Monetary or Material Support
|
| Emcure Pharmaceuticals Limited
Emcure House, T-184, M.I.D.C, Bhosari, Pune, Maharashtra, 411026 |
|
|
Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Limited |
| Address |
Emcure Pharmaceuticals Limited
Emcure House, T-184, M.I.D.C, Bhosari, Pune, Maharashtra, 411026 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahendra Pal Singh |
G.S.V.M. Medical College |
Swaroop Nagar,Kanpur,208002
Kanpur Nagar
UTTAR PRADESH |
8765379671
drmahendrapalsingh@gmail.com |
| Dr Gupta Sandeep kumar |
M.V. Hospital and Research Centre |
314/30, Mirza Mandi, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Jitendra Shukla |
Motilal Nehru Medical College |
Geroge Town, Civil Lines, Prayagraj, 211002
Allahabad
UTTAR PRADESH |
7007582452
drjitendramln@gmail.com |
| Dr Ketan Shah |
Navneet Memorial Hospital "SUSHRUSHA" |
Opp. Sardar Patel Seva,
Samaj Hall, In the Lane
Opp. Navrangpura Telephone Exchange,off C.G. Road, Navrangpura, Ahmedabad 380006
Ahmadabad
GUJARAT |
9825259052
drketanshah013@gmail.com |
| Dr Shuvra Neel Baul |
Nil Rahrm Sircar Medical College and Hospital |
138, AGC Bose Road, Kolkara, 700014
Kolkata
WEST BENGAL |
9062015351
shuvraneelb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College |
Submittted/Under Review |
| Ethics Committee of Navneet Memorial Hospital |
Approved |
| Ethics Committee, N.R.S. Medical College |
Submittted/Under Review |
| Inst.Ethics committee for MV Hospital and Research centre |
Submittted/Under Review |
| Institutional Ethics Committee, MLN Medical college |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract, (2) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Liposomal Amphotericin B injection 50mg/vial (Lyophilized) TRASPOR® |
Institute the therapy at a daily dose of 1 mg/kg bodyweight. Increase gradually to 3 mg/kg. Accumulated dose of 1 to 3g of Amphotericin B as Liposomal Amphotericin B over 3 to 4 weeks is normally recommended.
Infusion is given over a period of approximately 120 minutes or reduced to 60 minutes if it is well tolerated. (As per the TRASPOR® PI) |
| Comparator Agent |
Single arm trial |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
• Male and non- pregnant, non-lactating female patients of age ≥ 18 years of age.
• Patients who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (TRASPOR®) treatment as per Investigator’s discretion for current illness.
• Patients /LAR willing and able to give written informed consent according to applicable regulatory requirements. |
|
| ExclusionCriteria |
| Details |
• History of anaphylactic or other severe systemic reaction to Lipid based amphotericin B or any of its excipients.
• Patients suffering from any medical condition that in the investigator’s opinion could compromise the patient’s ability to participate in the clinical study.
• Patients participating prospectively in another clinical study within the last four weeks before the enrolment in the study.
• In the last six weeks, patients have taken any amphotericin B preparation other than TRASPOR®.
• Patients on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus.
• Pregnant or lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of TRASPOR(R) when administered as a treatment in invasive fungal infection (IFI) in patients who are refractory to or intolerant of conventional amphotericin B therapy.The safety data will be collected till the completion of TRASPOR (R) treatment or till discharge from hospital whichever is earlier. |
The safety data will be collected till the completion of TRASPOR(R) treatment or till discharge from hospital whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients with adverse event
Percentage of patients with treatment discontinuation due to study drug related adverse events |
Complition of Tretment or till the discharge from the hospital |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/10/2024 |
| 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="3"
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
|
The primary purpose of this study is to assess safety and effectiveness of Liposomal Amphotericin B injection 50mg/vial (Lyophilized) TRASPOR®, Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy. |