Health Condition 1: J329- Chronic sinusitis, unspecified Health Condition 2: null- The patients with invasive fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy as per physicianâ??s discretion.
Conditions
Interventions
Intervention1: Inj. Liposomal Amphotericin B
(Phosome) 50 mg: The subject will be administered
with liposomal Amphotericin B
(Phosome) (3 to 5 mg/kg/day)
infusion by the Physician or
designee as per l
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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 physicianâ??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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints 1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related). 2.Percentage of patients with adverse events. 3.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events. Timepoint: During the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMr Satish Marukurthi
Cipla Ltd
Outcome results
None listed