An observational study to evaluate the safety and tolerability of Amphotericin B Lipid suspension in patients with Invasive Fungal Infections.
- Conditions
- Health Condition 1: J329- Chronic sinusitis, unspecifiedHealth Condition 2: null- 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
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 <br/ ><br>1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related). <br/ ><br>2.Percentage of patients with adverse events. <br/ ><br>3.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events. <br/ ><br>Timepoint: During the treatment period. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable