| CTRI Number |
CTRI/2022/04/042124 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lipososmal Amphotericin B in treatment of patients with invasive fungal infection |
|
Scientific Title of Study
|
A Prospective, Multi-centre, Active Post-Marketing Surveillance Study of Liposomal Amphotericin B (Amphonex® - Manufactured by Bharat serums and Vaccines ltd) in Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy in Real World Clinical Practice (AMBeR) |
| Trial Acronym |
AMBeR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV_L-AMB_21_04 version 01 / 25 August 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Vice President - Medical Affairs |
| Affiliation |
Bharat serums and Vaccines LTd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
022-45043456 |
| Fax |
|
| Email |
Ramesh.Jagannathan@bsvgroup.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Vice President- Clinical Research and Pharmacovigilance |
| Affiliation |
Bharat serums and Vaccines LTd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
022-45043456 |
| Fax |
|
| Email |
Ramesh.jagannathan@bsvgroup.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Vice President- Clinical Research and Pharmacovigilance |
| Affiliation |
Bharat serums and Vaccines LTd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
022-45043456 |
| Fax |
|
| Email |
Ramesh.Jagannathan@bsvgroup.com |
|
|
Source of Monetary or Material Support
|
| Bharat Serums and Vaccines Ltd
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai MAHARASHTRA 400708 India |
|
|
Primary Sponsor
|
| Name |
Bharat Serums and Vaccines Ltd |
| Address |
3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi Mumbai MAHARASHTRA 400708 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uttam Kumar Nath |
All India Institute of Medical Sciences, Rishikesh |
All India Institute of Medical Sciences, Veerbhadra Marg, Rishikesh Uttarakhand-249203
Dehradun
UTTARANCHAL |
9433982756
uttam.monc@aiimsrishikesh.edu.in |
| Dr Rajendra Vajrapu |
Aware Gleneagles Global Hospitals |
08-16-01, Near Sagar X Roads Saroornagar LB Nagar 500035
Hyderabad
TELANGANA |
9959166641
rvajarapu@gmail.com |
| Dr Mahesh K M |
BMC &R Institute Victoria hospital, Bangalore |
Mysore-road, Near City Market, New Tharagupet, -560002,
Bangalore
KARNATAKA |
9986112661
drmaheshmysore@gmail.com |
| Dr Pavan Kumar Reddy |
Care Hospital |
Road No. 1, Banjara Hills, 500034,
Hyderabad
TELANGANA |
9490480182
pakure@gmail.com |
| Dr Sanjay Verma |
GSVM Medical College |
Department of Pulomonology, Murari Lal Chest hospital, Ganesh Shankar Vidyarthi Memorial Medical College, Swaroop Nagar, 208002
Kanpur Nagar
UTTAR PRADESH |
941575458
pitrialsgsvm@gmail.com |
| Dr Sachin Suresh Jadhav |
Health Care Global Enterprises Limited, Bangalore |
#8, P. Kalinga Rao Road, Sampangi Ram Nagar -560027
Bangalore
KARNATAKA |
9741351357
drsachinjadhav@hotmail.com |
| Dr Sambit Sahu |
Krishna Institute of MEdical Science ltd. |
Block-III, 2nd Floor, South Wing, 1-8-31/1/ Minister Road, ,Krishna Nagar Colony, Begumpet, Secunderabad -500003;
Hyderabad
TELANGANA |
9989005763
drsambit@kimshospitals.com |
| Dr Anand Nikalje |
Mahatma Gandhi Missions MC & H |
,N6, CIDCO, 431003
Aurangabad
MAHARASHTRA |
0240-6601423
anandnikalje@rediffmail.com |
| Dr Harish M Maheshwarappa |
Mazumdar Shaw Medical Center (Unit of Narayana Health) |
no. 258/A Bommasandra Industrial Area, Hosur Road -560099
Bangalore
KARNATAKA |
8095218493
harish.mallapuramaheshwarappa.dr@narayanahealth.org |
| Dr Sauren Panja |
NH-Rabindranath Tagore International Institute of Cardiac Sciences |
Premises No 1489 (124) , Mukundapur, E.M. Bypass 700099
Kolkata
WEST BENGAL |
9891279098
drsauren@yahoo.co.in |
| Dr Ameet Dravid |
Noble hospital |
Department of Infectious disease, Ground floor, Noble Hospital, 153, Magarpatta road, Magarpatta, Hadapsar, 411013,
Pune
MAHARASHTRA |
9975619766
ameet.dravid@gmail.com |
| Dr Ajoy Krishna Sarkar |
Peerless Hospitex Hospital and Research Center Limited |
360 Panchasayar,700094
Kolkata
WEST BENGAL |
9830006644
ajoysarkar29@gmail.com |
| Dr Raman Gaikwad |
Sahyadri Super Speciality Hosptial |
Sahyadri Super Speciality Hosptial, 30C, Erandwane, Karve Road, 411004
Pune
MAHARASHTRA |
8551891075
raman.gaikwad@sahyadrihospitals.com |
| Dr Dinesh Pendharkar |
Sarvodaya Cancer Institute (Sarvodaya Hospital) |
Sector-8, YMCA Road, Near Escort Mujesar, Metro Station, Sector 7 121006
Faridabad
HARYANA |
9987736665
drpendharkar@gmail.com |
| Dr Poorna Prasad S |
Shetty’s Hospital |
Plot No:11&12,12th F Main, Kaveri Nagar,
Kodichikkanahalli, Bommanahalli,560068
Bangalore
KARNATAKA |
9741941064
spoornaprasad123@gmail.com |
| Dr Arun Gangadhar |
Sri Ramakrishna Hospital |
No 395, Sarojini Naidu road, Sidhapudur, 641044
Coimbatore
TAMIL NADU |
9842285100
drgangadharanresearch1@gmail.com |
| Dr Mantri Sumant Narayan |
Sri Venkateshwara Hospitals |
#27, 29th Main Road, Rashtra Kuvempu Nagara, BTM 2nd Stage, BTM layout, 560076
Bangalore
KARNATAKA |
9900236821
svhospitalresearch@gmail.com |
| Dr Amrish Patel |
Sterling Hospital |
Sterling Hospital Road
Memnagar – 380052
Ahmadabad
GUJARAT |
9925166683
drarpatel79@yahoo.co.in |
| Dr Madhusudan Jaju |
Sunshine hospital |
Sunshine Hospital, 45, Survey No. 40 46, 7-56/19, Dargah Rd, LIG Chitrapuri Colony, Prashant Hills, Gachibowli 500032
Hyderabad
TELANGANA |
9440379476
madhu_jaju123@rediffmail.com |
| Dr Nagalingeswaran Kumarasamy |
VHS Infectious Disease Medical Centre |
CART Clinical Research Site Voluntary Health Services Rajiv Gandhi Salai, Taramani -600113
Chennai
TAMIL NADU |
9176912007
kumarasamy@cartcrs.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| 10_Institutional Ethics Committee Care Hospital Care Hospital |
Approved |
| 11_Sterling hospital Ethics Committee |
Approved |
| 12_Ethics CommitteeGSVM medical colleges |
Approved |
| 13_Institutional Ethics Committee Sarvodaya Hospital and Research Centre |
Approved |
| 14_Sahyadri Hospitals Pvt Ltd Ethics Committee |
Approved |
| 15_Sri Ramakrishna Hospital Ethical Committee |
Approved |
| 16_NHRTIICS Ethics committee |
Approved |
| 17_Institutional Ethics committee AIIMS, Rishikesh |
Approved |
| 18_VHS Institutional Ethics committee |
Approved |
| 19_HCG-Central Ethics Committee |
Approved |
| 1_Noble Hospital Institutional Ethics Committee |
Approved |
| 20_Ethics committee Bangalore MC&R Institute |
Approved |
| 2_Institutional Ethics Committee, Sunshine Hospitals. |
Approved |
| 3_Sri Venkateshwara Hospital Ethics committee |
Approved |
| 4_Shettys Hospital Ethics Committee |
Approved |
| 5_Institutional Ethics Committee Gleneagles Global hospitals |
Approved |
| 6_Clinical Research Ethics committee Peerless Hospitex Hospital and REsearch Center Ltd |
Approved |
| 7_Narayana Health Medical Ethics Committee |
Approved |
| 8_KIMS Ethics Committee |
Approved |
| 9_Ethics Committee for Research on Human Subjects- Mahatma Gandhi Mission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35-B49||Mycoses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amphonex® (Liposomal Amphotericin B for Injection) |
As per the prescribing information
daily dose of 1 mg/kg bodyweight increase gradually to 3 mg/kg
Route - intravenous |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either gender ≥ 18 years of age.
Subjects who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (Amphonex®) treatment as per Investigator’s discretion for current illness.
Subjects/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.
Subjects suffering from any medical condition that in the investigator’s opinion could compromise the subject’s ability to participate in the clinical study.
Subject participating prospectively in another clinical study within the last four weeks before the enrolment to the study.
In the last six weeks Subject have taken any amphotericin B preparation other than Amphonex®.
Subjects on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus.
Pregnant or nursing females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidences of Serious adverse events (SAEs) and adverse events (AEs) which are (serious/non-serious, expected/unexpected, related to the study drug) reported during the study. |
Throughout the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects with adverse events |
Throughout the study |
| Percentage of subjects with treatment discontinuation due to study drug-related adverse events |
Throughout the study |
|
|
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)
|
26/04/2022 |
| 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="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, multicenter, active post-marketing surveillance study for evaluation of the safety of Amphonex® in IFI patients who are refractory to or intolerant of conventional Amphotericin B therapy in real-world clinical practice.
All relevant information on the health condition of the subjects will be collected daily till the subject is discharged from the hospital. All TEAEs will be noted and analyzed.
|