Observational, Postmarketing Study to Evaluate the Safety of AmBisome®

Not Applicable

Conditions: Health Condition 1: B44- AspergillosisHealth Condition 2: B40- BlastomycosisHealth Condition 3: B37- CandidiasisHealth Condition 4: B38- CoccidioidomycosisHealth Condition 5: B45- CryptococcosisHealth Condition 6: B39- HistoplasmosisHealth Condition 7: B55- LeishmaniasisHealth Condition 8: B552- Mucocutaneous leishmaniasisHealth Condition 9: B465- Mucormycosis, unspecifiedHealth Condition 10: B49- Unspecified mycosis

Registration Number: CTRI/2023/08/057070

Lead Sponsor: Gilead Sciences Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Male or female patient older than 1 month (inclusive) at the time AmBisome treatment was started

2) Patients who have commenced treatment with AmBisome in accordance with the local routine clinical practice at any time between 01 June 2021 and 30 September 2022 (inclusive)

Exclusion Criteria

1) Patients treated by AmBisome in the framework of a clinical study

2) Patients who initiated treatment with other amphotericin B products, including liposomal amphotericin B products

3) Patients who initiated AmBisome treatment but switched to other amphotericin B products, including other liposomal amphotericin B products, due to non-clinical reasons (e.g. supply issues)

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is to evaluate the safety of AmBisome among pediatric and adult patients treated in India in accordance with the local routine clinical practice. This will be descriptive stats only, so we will describe all safety events occurring during the observation period.Timepoint: There is no specific time point to assess the outcome, as this is a retrospective non-interventional study to describe the safety profile of AmBisome in real-life setting. Only descriptive statistics will be used, describing all types of safety events collected throughout the study duration.

Secondary Outcome Measures