Lipososmal Amphotericin B in treatment of patients with invasive fungal infection

Not Applicable

Recruiting

• Conditions: Mycoses,

• Registration Number: CTRI/2022/04/042124
• Lead Sponsor: Bharat Serums and Vaccines Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-26
• Last Update Posted: 2023-08-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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.	Throughout the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

Aware Gleneagles Global Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Care Hospital; 🇮🇳 Hyderabad, TELANGANA, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Krishna Institute of MEdical Science ltd.; 🇮🇳 Hyderabad, TELANGANA, India

Mahatma Gandhi Missions MC & H; 🇮🇳 Aurangabad, MAHARASHTRA, India

Mazumdar Shaw Medical Center (Unit of Narayana Health); 🇮🇳 Bangalore, KARNATAKA, India

NH-Rabindranath Tagore International Institute of Cardiac Sciences; 🇮🇳 Kolkata, WEST BENGAL, India

Noble hospital; 🇮🇳 Pune, MAHARASHTRA, India

Peerless Hospitex Hospital and Research Center Limited; 🇮🇳 Kolkata, WEST BENGAL, India

Sahyadri Super Speciality Hosptial; 🇮🇳 Pune, MAHARASHTRA, India

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Aware Gleneagles Global Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr Rajendra Vajrapu

Principal investigator

9959166641

rvajarapu@gmail.com