ISRCTN - ISRCTN52812742: 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

Plain English Summary

Not provided at time of registration

Trial website

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

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

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