A Prospective Study to Assess Safety of Single-Dose Regimen at Two Dose Levels of FUNGISOME TM inTreatment of Visceral Leishmaniasis (Kala-Azar)
- Conditions
- Health Condition 1: null- Visceral Leishmaniasis (Kala-Azar)
- Registration Number
- CTRI/2011/11/002145
- Lead Sponsor
- ifecare Innovations Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Males and females between 12 and 60 years of age (both inclusive)
• Fever ( >99oF) with one or more of the following:
• Weight loss and/or decrease in appetite
• Enlarged spleen
• Anaemia (5<=Hb <=10 g/dl)
• Diagnosis of visceral leishmaniasis confirmed with bone marrow or splenic
aspirate
• Clinically stable and willing to attend the out-patient department for followup
as necessary
• Written informed consent from the patient or from parent or guardian if
under 18 years old
Any past history of treatment of VL during last 45 days
• History of Hepatitis B, C or known HIV-positive individual
• Active tuberculosis or on anti-tubercular drugs
• Patients using other antileishmanial drugs
• Those who have known hypersensitivity/allergy to the study drugs or their
constituents.
• Patients who have associated disease known to alter liver/kidney functions
• Pregnant or lactating women
• Women of child bearing age refusing/cannot assure use of contraceptive
method during treatment period plus 3 months thereafter
• Other serious illness or medical condition that in the opinion of the
investigator would interfere with the patientâ??s ability to receive any of the
study treatments or comply with study procedures or may affect the safety
of the patient when treated with study drugs
• Patients who have received any investigational drug within the last 6
months
• Serum creatinine or BUN 1.5 times the upper limit of normal
• Any concomitant drug that is nephrotoxic
• Signs/symptoms indicative of severe VL
• Platelet count 40, 000 per cubic millimeter
Bilirubin 2mg/deciliter
• Prothrombin time of more than 5 seconds above the control levels
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety of single dose of 10mg/kg and 15mg/kg FUNGISOME TM i.v. for <br/ ><br>treatment of visceral leishmaniasisTimepoint: 30 days post treatment
- Secondary Outcome Measures
Name Time Method To evaluate the initial cure at Day 30 post treatment with single dose of 10mg/kg and <br/ ><br>15mg/kg FUNGISOME TM i.v. for treatment of visceral leishmaniasisTimepoint: Day 30