A study to determine safety and effectiveness of Liposomal Amphotericin B injection 50mg per vial (Lyophilized) TRASPOR(R), Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy.

A Prospective, Multi-centre, Active Post-Marketing Surveillance Study of Liposomal Amphotericin B injection 50mg per vial (Lyophilized) TRASPOR (R) Manufactured by Emcure Pharmaceuticals LTD. in Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy in Real World Clinical Practice - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/09/074381

Enrollment

250

Registered

2024-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J069- Acute upper respiratory infection,unspecified Health Condition 2: J398- Other specified diseases of upperrespiratory tract

Interventions

Intervention1: Liposomal Amphotericin B injection 50 mg/vial (Lyophilized) TRASPOR®: Adults and Children: ? Institute the therapy at a daily dose of 1 mg/kg bodyweight. Increase gradually to 3 mg/kg.

Eligibility

Inclusion criteria

Inclusion criteria: • Male and non- pregnant, non-lactating female patients of age = 18 years of age. • Patients who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (TRASPOR®) treatment as per Investigator’s discretion for current illness. • Patients /LAR willing and able to give written informed consent according to applicable regulatory requirements.

Exclusion criteria

Exclusion criteria: • History of anaphylactic or other severe systemic reaction to Lipid based amphotericin B or any of its excipients. • Patients suffering from any medical condition that in the investigator’s opinion could compromise the patient’s ability to participate in the clinical study. • Patients participating prospectively in another clinical study within the last four weeks before the enrolment in the study. • In the last six weeks, patients have taken any amphotericin B preparation other than TRASPOR®. • Patients on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus. • Pregnant or lactating females.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of TRASPOR(R) when administered as a treatment in invasive fungal infection (IFI) in patients who are refractory to or intolerant of conventional amphotericin B therapy.The safety data will be collected till the completion of TRASPOR (R) treatment or till discharge from hospital whichever is earlier.Timepoint: The safety data will be collected till the completion of TRASPOR(R) treatment or till discharge from hospital whichever is earlier.	—

Measure

Time frame

To evaluate the safety of TRASPOR(R) when administered as a treatment in invasive fungal infection (IFI) in patients who are refractory to or intolerant of conventional amphotericin B therapy.The safety data will be collected till the completion of TRASPOR (R) treatment or till discharge from hospital whichever is earlier.Timepoint: The safety data will be collected till the completion of TRASPOR(R) treatment or till discharge from hospital whichever is earlier.

—

Secondary

Measure	Time frame
Percentage of patients with adverse event Percentage of patients with treatment discontinuation due to study drug related adverse eventsTimepoint: Complition of Tretment or till the discharge from the hospital	—

Countries

India

Contacts

Public ContactKrunal Patel

Emcure Pharmaceuticals Limited

neha.vala@emcure.com7930640153

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026