ipososmal Amphotericin B in treatment of patients with invasive fungal infectio
- Conditions
- Health Condition 1: B35-B49- Mycoses
- Registration Number
- CTRI/2022/04/042124
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 Investigatorâ??s discretion for current illness.
Subjects/LAR willing and able to give written informed consent according to applicable regulatory requirements.
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 investigatorâ??s opinion could compromise the subjectâ??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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Throughout the study
- Secondary Outcome Measures
Name Time Method Percentage of subjects with adverse eventsTimepoint: Throughout the study;Percentage of subjects with treatment discontinuation due to study drug-related adverse eventsTimepoint: Throughout the study