Health Condition 1: null- Visceral Leishmaniasis
Conditions
Interventions
Intervention1: Liposomal Amphotericin B: Single dose of 10mg/kg
Intervention2: Liposomal Amphotericin B: single dose of 15mg/kg
Intervention3: Liposomal Amphotericin B and Miltefosine: single dose of
Sponsors
Lifecare Innovations Private Limited
Department of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: • Males and females between 5 and 60 years of age (both inclusive) • History of fever ( >99oF) in last two weeks with one or more of the following: - Weight loss and/or decrease in appetite - Enlarged spleen - Anaemia (5 - Diagnosis of visceral leishmaniasis confirmed with splenic or bone marrow aspirate - Clinically stable and appropriate for treatment; and willing to attend the out-patient department for follow-up as necessary for 6 months - Written informed consent from the patient or from parent or guardian if patient is under 18 years of age
Exclusion criteria
Exclusion criteria: • Any past history of treatment of VL during last 45 days • History of Hepatitis B, C, or 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 - Prothrombin time >5 seconds above the control levels - Bilirubin >2mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare efficacy of 10 mg/kg and 15 mg/kg single doses of FUNGISOMETM i.v. given alone and a combination of single dose 5 mg/kg FUNGISOMETM i.v. followed by Miltefosine given orally for 7 days, versus reference therapy of 10 mg/kg single dose of AmBisome® for VL treatment at 6 Month post-treatment.Timepoint: 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare efficacy of 10 mg/kg and 15 mg/kg single doses of FUNGISOMETM i.v. given alone and a combination of single dose 5 mg/kg FUNGISOMETM i.v. followed by Miltefosine given orally for 7 days, versus reference therapy of 10 mg/kg single dose of AmBisome® for VL treatment at Day 30Timepoint: Day 30;To evaluate and compare safety of 10 mg/kg and 15 mg/kg single doses of FUNGISOMETM i.v. given alone and a combination of single dose 5 mg/kg FUNGISOMETM i.v. followed by Miltefosine given orally for 7 days, versus reference therapy with 10 mg/kg single dose of AmBisome® for treatment of VL up to 6 Month post-treatmentTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Ranjana K Seth
Lifecare Innovations Private Limited
Outcome results
None listed