Cryptococcal meningitis Infections and Infestations Cryptococcal meningitis
Conditions
Interventions
Indian liposomal amphotericin B (Fungisome) 3 mg/kg/day versus 1 mg/kg/day)
The proportion of patients for clinical and microbiological response time at day 7 (± standard deviation [SD] 3 days ) for
Sponsors
Government of India (India) - Department of Biotechnology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with systemic fungal infections must have at least one of the following criteria: 1.1. Cryptococcal meningitis or cryptococcal infections at any other site 1.2.. Documented by typical clinical signs and symptoms and confirmed by cerebral spinal fluid (CSF) culture or tissue culture and/or histology. Culture results may be pending at the time of enrolment, if direct microscopy (India ink preparation) reveals cryptococcal species. 2. Patients and/or legally authorized representative(s), if applicable, have been fully informed and have given written informed consent. A patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person. 3. Patient can be neonates, pediatric patients or adults of either gender (0-28 days, 28 days -18 years and >18 years) 4. Female patients of child bearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. They must avoid becoming pregnant while receiving study medication by maintaining adequate birth control practice 5. Patients must have sufficient venous access to permit administration of study medication and monitoring of safety variables 29 patients per treatment group are needed in the protocol set to conclude superiority with power of 90%. With an expected rate of 20% drop out, it is planned that 64 patients will be randomised, receiving 8 doses or more who meet eligibility criteria.
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant or nursing 2. Patient with evidence of liver disease as defined by: 2.1. Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) >10 times the upper limit of normal (ULN) 2.2. Total bilirubin >5 times ULN 3. Patients whose sole diagnosis is oropharygeal and/or oesophageal candidiasis 4. Patients with history of allergy, hypersensitivity, or any serious reaction to, Fungisome or any product containing amphotericin B 5. Patient previously enrolled into this study 6. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or human immunodeficiency virus (HIV) 7. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk 8. Patients with a life expectancy judged to be less than five days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the based on following criteria: 1. Duration of treatment with Fungisome 3 mg/kg/day versus Fungisome 1 mg/kg/day 2. Total dose given with Fungisome 3 mg/kg/day versus Fungisome 1 mg/kg/day 3. Response time for resolution of symptom and signs of fungal infection 4. Response time for microbiological conversion 5. Total Cost of two treatment regimens at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end point is the investigator assessment of overall safety and efficacy of two treatment regimens at the end of therapy | — |
Countries
India
Outcome results
None listed