CTRI/2017/08/009429 [Registered on: 21/08/2017] Trial Registered Prospectively
Last Modified On:
08/08/2025
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
An observational study to evaluate the safety and tolerability of Amphotericin B Lipid suspension in patients with Invasive Fungal Infections.
Scientific Title of Study
An observational, practice based, open label, prospective, non-comparative, multicenter, post marketing surveillance to assess safety and tolerability of Liposomal Amphotericin B (Phosome) in patients with Invasive Fungal Infection who are refractory to or intolerant of conventional Amphotericin B therapy.
Rajiv Gandhi Institute of Medical Sciences & Govt. General Hospital
Department of Surgery,
Research Wing, 2nd Floor, Beside FM Ward, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam ANDHRA PRADESH
9849702720
drprasadarao@gmail.com
Dr Harsh Toshniwal
Sterling Hospitals
Department of Intensive Care Unit,
Near Maharaj Agrasen Vidhyalaya,
Near Gurkul,
Sterling Hospital Road, Nilmani society,
Memnagar,
Ahmedabad,
Gujarat - 380052 Ahmadabad GUJARAT
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, The patients with invasive fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy as per physician’s discretion.,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Inj. Liposomal Amphotericin B
(Phosome) 50 mg
The subject will be administered
with liposomal Amphotericin B
(Phosome) (3 to 5 mg/kg/day)
infusion by the Physician or
designee as per local hospital
protocols.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Written signed and dated informed consent (patient or LAR).
2.Either gender with age ≥18 years.
3.Patients with Invasive Fungal Infection (IFI) who are refractory to or intolerant of conventional Amphotericin B therapy, as per physician’s discretion.
4.Culture proven Aspergillus, Candida, Cryptococcus Invasive Fungal Infection (IFI).
5.Patients who are either treatment naïve to Liposomal Amphotericin B or have started Liposomal Amphotericin B treatment within 5 days for the current Invasive Fungal Infection episode.
ExclusionCriteria
Details
1.Known hypersensitivity to Liposomal Amphotericin B or any of its components
2.Pregnant or nursing females
3.Any other condition in the opinion of the investigator would affect the safety of the patient if Liposomal Amphotericin B is administered.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Safety Endpoints
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related).
2.Percentage of patients with adverse events.
3.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events.
During the treatment period.
Secondary Outcome
Outcome
TimePoints
Not Applicable
Not Applicable
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"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is an observational, practice based, open label, multicenter, post marketing surveillance study. This study is to assess the safety and tolerability of Liposomal Amphotericin B (Phosome – a Cipla Ltd. product) in patients with Invasive Fungal Infection who are refractory to or intolerant of conventional Amphotericin B therapy.Patients who are hospitalized with a confirmed (culture and sensitive to Liposomal Amphotericin B) Invasive Fungal Infection (IFI) will be enrolled into this study. The study treatment and study duration will be at the investigators discretion.Each patient will participate in this study for about 2 weeks. The study duration may extend based on the treatment period required by the patient at the discretion of the investigator. Patients who require anticipated duration of antifungal treatment more than 12 weeks and /or surgery for the fungal infection will not be enrolled into the study.