An observational study to evaluate the safety and tolerability of Amphotericin B Lipid suspension in patients with Invasive Fungal Infections.

Not Applicable

Recruiting

• Conditions: 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.,

• Registration Number: CTRI/2017/08/009429
• Lead Sponsor: Cipla Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-09
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

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

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Endpoints	During the treatment period.
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related).	During the treatment period.
2.Percentage of patients with adverse events.	During the treatment period.
3.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events.	During the treatment period.

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (16)

Alexis Multi-Speciality Hospital Private Limited; 🇮🇳 Nagpur, MAHARASHTRA, India

Apollo Hospitals Enterprise Limited; 🇮🇳 Mumbai, MAHARASHTRA, India

CARE Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Fortis Hospital Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, HARYANA, India

Gandhi Medical College & Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Max Smart Super Speciality Hospital; 🇮🇳 West, DELHI, India

Max Super Speciality Hospital, Vaishali – A unit of Crosslay Remedies Ltd; 🇮🇳 Ghaziabad, UTTAR PRADESH, India

Mazumdar Shaw Medical Center A Unit of Narayana Hrudayalaya; 🇮🇳 Bangalore, KARNATAKA, India

NH Narayana Superspeciality Hospital; 🇮🇳 Kamrup, ASSAM, India

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Alexis Multi-Speciality Hospital Private Limited

🇮🇳Nagpur, MAHARASHTRA, India

Dr Nitin Rameshrao Shinde

Principal investigator

9405528123

dr.nitinshinde@gmail.com