Health Condition 1: B550- Visceral leishmaniasis
Conditions
Interventions
Intervention1: Amphotericin B Emulsion (Amphomul): 15mg/kg single bolus dose
Control Intervention1: Liposomal Amphotericin B (AmBisome): 15mg/kg single bolus dose
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 5 to 65 years (both inclusive). 2. Patient/patient's legally acceptable representative (LAR) is willing and able to give written informed consent to participate in the study. 3. Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly) 4. Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by recombinant K39 protein (rK39) dipstick test with confirmation of Kala-azar by splenic or bone marrow aspirate smear examination. 5. No previous treatment for Visceral Leishmaniasis within 30 days from screening. 6. Non-pregnant, non-lactating females of age equal to or greater than 5 years, and woman of childbearing potential (any woman who has reached menarche) who are willing to use acceptable methods of contraception like long term acting injections ex. Depo-Provera. 7. Negative Urine pregnancy test (UPT) in all women physiologically capable of becoming pregnant (any woman who has reached menarche) 8. Hemoglobin equal to or greater than 5 g/dL 9. White blood cells (WBC) count equal to or greater than 1000/cmm 10. Platelet count equal to or greater than 50000/cmm 11. Alanine amino transferase (ALT), aspartate amino transferase (AST) and alkaline phosphatase equal to or less than 2.5 times the upper limit of normal (ULN) 12. Prothrombin time equal to or less than 4 seconds above the control. 13. Normal serum creatinine and serum potassium levels 14. Negative tests for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B surface antigen (HBsAg).
Exclusion criteria
Exclusion criteria: 1. Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening. 2. Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history). 3. A history or evidence of any concurrent disease that may be serious or life threatening, significant hematological, cardiac, hepatic, renal, respiratory, neurological or metabolic disease or any condition which, in the opinion of the investigator, may constitute a safety concern or interfere with the evaluation of the study objectives or may prevent the patient from the completing study therapy or subsequent follow-up 4. Concurrent diabetes, tuberculosis or bacterial pneumonia (on chest X-ray, erythrocyte sedimentation rate (ESR) at screening, past history) or any other infectious or major psychiatric disease. 5. Patients with concurrent Malaria will not be included in the trial. Parascreen antigen test for detection of malarial parasites will be performed at screening visit. Patients diagnosed with malaria could be rescreened for enrollment in the trial after adequate treatment of Malaria; and if the parascreen antigen test for detection of malarial parasites is found negative then the patient could be enrolled in the trial. 6. History of major surgery within 2 weeks prior to screening 7. Blood urea nitrogen (BUN) and serum creatinine >1.5 times ULN, and serum bilirubin >1.5 times ULN 8. Proteinurea equal to or greater than 2+ 9. Pregnant or nursing women 10. History of alcoholism or illicit drug use/ abuse, or any condition associated with poor compliance 11. Known hypersensitivity to Amphotericin B, inactive ingredients of Amphomul® formulation, inactive ingredients of AmBisome formulation. 12. Patients receiving any of the medications prohibited by the study protocol. 13. Simultaneous participation in another trial or received any IP less than 30 days prior to enrolment. 14. Any condition which in the investigator's opinion may prevent the patient from completing the study therapy or follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Initial cure (splenic aspirate score 0) 2. Clinical improvement after study drug administration o Absence of fever; and >1 out of following: ? Increase in hemoglobin concentration by >10% compared to baseline ? Any weight gain compared to the baseline visit ? Decrease in spleen size by >33% from baseline Timepoint: 1. Day 30 or Day 45 2. Day 30;1. Initial cure (splenic aspirate score on Day 30 and 45) 2. Clinical improvement on Day 30 after first dose of study drug o Absence of fever; and >1 out of following: Increase in hemoglobin concentration by ≥10% compared to baseline Weight gain compared to baseline visit Decrease in spleen size by >33% compared to baseline Timepoint: 1. Day 30 or Day 45 2. Day 30;o Definitive cure 1. Initial cure at Day 30 or Day 45 2. No signs and symptoms of relapse of Kala-azar for 6 months after study drug administration. If signs and symptoms of relapse of the disease are suspected at any time during the 6 months follow up, splenic aspirate shall be performed at 6 months or earlier after study drug administration. Proportion of patients achieving all three-efficacy endpoints will be compared across the two groups. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of DLTs. 2. Incidence of IRTs 3. Incidence of nephrotoxicity and hepatotoxicity 4. Number of AEs and SAEs 5. Laboratory values for different parameters Timepoint: 6 months;? Incidence of DLTs. ? Incidence of IRTs ? Incidence of nephrotoxicity and hepatotoxicity ? Number of AEs and SAEs ? Laboratory values for different parameters Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactTaref Kanthawala
Bharat Serums and Vaccines Ltd.
Outcome results
None listed