A multicentric, open, comparative, randomized, study to optimize dose, duration, safety, efficacy, and cost of two treatment regimens with liposomal amphotericin (Fungisome) in the treatment of systemic infection in India

ISRCTN ISRCTN52812742
DOI https://doi.org/10.1186/ISRCTN52812742
Secondary identifying numbers SFI
Submission date
23/03/2006
Registration date
19/05/2006
Last edited
06/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nilima Kshirsagar
Scientific

Department of Clinical Pharmacology
Seth GS Medical College and KEM Hospital
Parel
Mumbai
400012
India

Phone +91 (0)22 24174420
Email dcpkem@vsnl.com

Study information

Study designMulticentre open label comparative randomised study to optimize dose duration safety and efficacy
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA multicentric, open, comparative, randomized, study to optimize dose, duration, safety, efficacy, and cost of two treatment regimens with liposomal amphotericin (Fungisome) in the treatment of systemic infection in India
Study objectives1. 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(s)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)
Health condition(s) or problem(s) studiedCryptococcal meningitis
InterventionIndian 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Liposomal amphotericin (Fungisome)
Primary outcome measureThe 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 measuresThe secondary end point is the investigator assessment of overall safety and efficacy of two treatment regimens at the end of therapy
Overall study start date07/03/2006
Completion date06/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants64
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment07/03/2006
Date of final enrolment06/03/2007

Locations

Countries of recruitment

  • India

Study participating centre

Department of Clinical Pharmacology
Mumbai
400012
India

Sponsor information

Government of India (India) - Department of Biotechnology
Government

Department of Biotechnology
Government of India
New delhi
110003
India

Phone +91 (0)22 24363722
Email suchita.ninave@dbt.nic.in
Website http://www.dbt.nic.in
ROR logo "ROR" https://ror.org/03tjsyq23

Funders

Funder type

Government

Government of India (India) - Department of Biotechnology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2010 06/01/2021 Yes No

Editorial Notes

06/01/2021: Publication reference added.