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CTRI Number  CTRI/2022/08/044680 [Registered on: 05/08/2022] Trial Registered Prospectively
Last Modified On: 26/05/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Post Marketing surveillance study to evaluate the safey of liposomal Amphotericine B (Gufisome)inpatient of Invasive fungal infection 
Scientific Title of Study   A post marketing surveillance study to assess safety and tolerability of Liposomal Amphotericin B Injection (GUFISOME) in patients with Invasive Fungal Infection who are refractory to or intolerant of conventional Amphotericin B therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GB_LAB_001_21 Version No.01 dated 16.02.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adarsh Shetty 
Designation  Senior Manager - Medical Affairs 
Affiliation  Gufic Biosciences Limited 
Address  Gufic Biosciences Limited Subhash Road A Block Vile East

Mumbai
MAHARASHTRA
400057
India 
Phone  91844968062  
Fax    
Email  dr.adarsh.shetty@guficbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adarsh Shetty 
Designation  Senior Manager - Medical Affairs 
Affiliation  Gufic Biosciences Limited 
Address  Gufic Biosciences Limited Subhash Road A Block Vile East


MAHARASHTRA
400057
India 
Phone  91844968062  
Fax    
Email  dr.adarsh.shetty@guficbio.com  
 
Details of Contact Person
Public Query  
Name  Mr Vairamuthu Ammaiyappan 
Designation  Associate Director 
Affiliation  iDD Research Solutions Pvt Ltd 
Address  4th Floor Ektha Serene located at 103 H G B and 104 HIG B Survey No 132 APHB Colony Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  919606829331  
Fax    
Email  vairamuthu.ammaiyappan@iddresearch.com  
 
Source of Monetary or Material Support  
Gufic Biosciences Limited,Subhash Road-A Block,Vile Parle East Mumbai,Maharashtra-400057 
 
Primary Sponsor  
Name  Gufic Biosciences Limited 
Address  Subhash Road-A Block,Vile Parle East Mumbai,Maharashtra-400057 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitin Shinde  Advance Critical Care - Gillurkar Multispeciality Hospital  Gillurkar Multispeciality Hospital, 20, Reshimbag, Umred Road, Nagpur - 440009, Maharashtra.
Nagpur
MAHARASHTRA 		 9405528123

dr.nitinshinde@gmail.com 
Dr Sandip Sinha  College of Medicine and Sagore Dutta Hospital  Department of Anesthesiology first floor, Hospital Building OT Complex 578 BT Road kamarhati
Kolkata
WEST BENGAL 		 8777314051

dr.sandipsinha72@yahoo.in 
Dr Kapil Sarde  Dr. Babasaheb Ambedkar Memorial Hospital  Dr. Baba Saheb Ambedkar Road, Byculla east, Byculla, Mumbai - 400027, Maharashtra
Mumbai
MAHARASHTRA 		 9975443902

kapilsarde@gmail.com 
Dr Govardhan Rao  Excel Hopspital  General Medicine,Room No:103, 104, 1st Floor, 1-5-56/29, Old Alwal Road, Beside Bharat Petroleum,Near IG Statue, Banda Basti, Alwal, Secunderabad, Telangana-500010
Hyderabad
TELANGANA 		 7731030321

drgovardhanmd1278@gmail.com 
Dr Neha Rastogi  Fortis Memorial Research Institute  Department of Infectious Disesases, Sector-44, Opposite Huda city centre,
Gurgaon
HARYANA 		 9582777566
122002
neha.rstg@gmail.com 
Dr Nand Kishore   Himalayan Institute of Medical Sciences.  Himalayan Institute of Medical Sciences, Swami Rama Himalayan University Campus, Jolly Grant, Dehradun, Uttrakhand-248140 India.
Dehradun
UTTARANCHAL 		 7906913453

drnanda75@gmail.com 
Dr Vijay Barge  RCSMGMC and CPR Hospital  Medicine department, 3rd Floor, Vedganga Building, Dasara chowk bhausinji Road Town hall
Kolhapur
MAHARASHTRA 		 9011066766

drvijaybarge12@gmail.com 
Dr Chihrag Chhatwani  Shalby Hospital  Department-Infectious Diseases(OPD), First Floor, Surat,Near Navyug College,Rauder-Road, Adajan, Surat- 395005
Surat
GUJARAT 		 9913224898

dr.chiragchhatwani@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Bharatratna Dr. Babasaheb Ambedkar Memorial Hospital Ethics Committee  Approved 
Ethics committee shalby Ltd  Approved 
Ethics Committee Swami Rama Himalayan University  Approved 
Excel Hospital Institutional ethics committee  Approved 
Gillurkar Hospital Ethics Committee  Approved 
Institutional Ethics committee College of Medicine and Sagore Dutta Hospital  Approved 
Rajashree Chhatrapati shahu Maharaj govt. Medical Collegeand chharapti pramila Raje Hospital Institutional ethics committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B35-B49||Mycoses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liposomal Amphotericine B  GUFISOME (Liposomal Amphotericin B) Composition: Each Vial contains – Amphotericin I.P …………50 mg Dosage form and strength: Gufisome is supplied in glass vials containing sterile lyophilized powder equivalent to 50mg of Liposomal Amphotericin B. Doses: 1-3 mg/kg body weight Route of administarion: intravenous infusion over a 30 – 60 minute period. The recommended concentration for intravenous infusion is 0.2 mg/ml to 2.0 mg/ml. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male/female patients aged ≥ 18 years at the time of consent.
2. Patients with clinical and mycological diagnosis of Invasive Fungal Infection, who are refractory to or intolerant of conventional Amphotericin B therapy.
3 Confirmed invasive fungal infection by the presence of moulds or yeasts in a deep tissue biopsy or a culture obtained by a sterile procedure (Mucormycosis, Aspergillus, Candida, Pneumocystis and Cryptococcus spp.)
4. Patients who are either treatment naive to Liposomal Amphotericin B or for the current Invasive Fungal Infection episode.
5. Patients who are willing to give voluntary written informed consent. 
 
ExclusionCriteria 
Details  1.Patients with Life expectancy below 72 hours.
2.Patients with known history of hypersensitivity to Liposomal Amphotericin B or any of its components.
3.Patients with any other condition, in the opinion of the investigator, which would affect the safety of the patient if Liposomal Amphotericin B is administered.
4.Patients with history of intolerance to Amphotericin B.
5.Patients with Clinically significant screening laboratory parameters in the opinion of the investigator ((Eg.Hemoglobin of >5 g/dL,serum creatinine>2mg/dL or creatinine clearance < 50 mL/min, ALT & AST > 5 UNL).
6.History of uncontrolled diseases, such as DM, hypertension; clinically significant Hematopoietic, renal, hepatic, electrolyte disorders, thyroidal dysfunction, angina pectoralis, serious cardiac arrhythmias, serious heart failure, neuropsychiatric infection, immunocompromised or any other disease in the opinion of the investigator.
7.Female patients who are breast-feeding/ pregnant, or intends to become pregnant during the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
All Treatment emergent Adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related).(Time Frame at Visit 1/baseline & at Visit 2/post-treatment)  Visit 1 baseline and at Visit 2 post-treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients with adverse events.  Visit 1 baseline and Visit3 End of study day 28  
Treatment discontinuation rates Early discontinuation, discontinuation due to adverse events  Visit 1 basline to visit 2 post treatment 
Resolution of fever at the end of treatment, “resolution of fever”, defined as the axillary temperature, at the end of treatment, of ≤37°C with a decrease of ≥ 1°C from the initial body temperature  Visit 1 baseline and at Visit 2 post-treatment 
Overall clinical response rate to treatment defined as
a) Mycological eradication post-treatment. [Time Frame: at Visit 1/Screening & at Visit 2/Post-treatment]
b) Clinical cure or improvement of clinical signs and symptoms post-treatment. [Time Frame: at Visit 1/Baseline & Visit 2/Post-treatment] 		 Visit 1 baseline and at Visit 2 post-treatment 
Percentage of patients who are tolerable to Liposomal Amphotericin B.  at Visit 2 post-treatment 
 
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)   10/08/2022 
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="0"
Months="1"
Days="0" 
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   A post marketing surveillance study to assess safety and tolerability of Liposomal Amphotericin B Injection (GUFISOME) in patients with Invasive Fungal Infection.
Total 250 subjects will be enrolled in the study.
 
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