Contact information
Type
Scientific
Primary contact
Dr Nilima Kshirsagar
ORCID ID
Contact details
Department of Clinical Pharmacology
Seth GS Medical College and KEM Hospital
Parel
Mumbai
400012
India
+91 (0)22 24174420
dcpkem@vsnl.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SFI
Study information
Scientific title
Acronym
Study hypothesis
1. To compare safety, efficacy, duration of treatment and cost of 3 mg/kg/day of liposomal amphotericin (Fungisome) given for a short duration with 1 mg/kg in the previous trial in systemic fungal infections
2. Duration of treatment with Fungisome 3 mg/kg/day versus Fungisome 1 mg/kg/day
3. Total dose given with Fungisome 3 mg/kg/day versus Fungisome 1 mg/kg/day
4. Response time for resolution of symptom and signs of fungal infection
5. Response time for microbiological conversion
6. Total cost of two treatment regimens at the end of study
Ethics approval
1. The Institutional Ethics Committee (IEC) and Institutional Review Board (IRB) of Seth GS Medical College and KEM Hospital, Mumbai, approved on the 9th of December 2005 (ref: EC/GOV-5/2005)
2. The Institutional Ethics Committee of Christian Medical College, Vellore, approved on the 21st of December 2005 (ref: EcMin IRB(EC) 8/12/05)
3. The Institutional Ethics Committee of Nizams Institute of Medical Sciences, Hyderabad, approved on the 16th of December 2005 (ref: 13/1/99/A6)
4. The Institutional Ethics Committee of Post Graduate Institute of Medical Sciences and Research, Chandigarh, approved on the 17th og March 2006 (ref: EC/06-450)
5. The Institutional Ethics Commitee of All India Institute of Medical Research approved on the 10th of March 2006 (ref: A-11: 07/12/2005)
Study design
Multicentre open label comparative randomised study to optimize dose duration safety and efficacy
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cryptococcal meningitis
Intervention
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 Fungisome 1 mg/kg/day is 40% as compared to expected 80% in 3 mg/kg/day. To detect the difference of 40% with an alpha of 0.05 (two sided)
Intervention type
Drug
Phase
Not Specified
Drug names
Liposomal amphotericin (Fungisome)
Primary outcome measure
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 outcome measures
The secondary end point is the investigator assessment of overall safety and efficacy of two treatment regimens at the end of therapy
Overall trial start date
07/03/2006
Overall trial end date
06/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant 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
Recruitment start date
07/03/2006
Recruitment end date
06/03/2007
Locations
Countries of recruitment
India
Trial participating centre
Department of Clinical Pharmacology
Mumbai
400012
India
Sponsor information
Organisation
Government of India (India) - Department of Biotechnology
Sponsor details
Department of Biotechnology
Government of India
New delhi
110003
India
+91 (0)22 24363722
suchita.ninave@dbt.nic.in
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Government of India (India) - Department of Biotechnology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list