Single dose study of Liposomal Amphotericin (Ambisome).

Rationalization of single dose 10 mg/kg/bw and 15 mg /kg/bw as compared to 5 mg/kg/bw for four days of Liposomal Amphotericin B with special reference to efficacy and safety profile for treatment of visceral leishmaniasis in Bihar, India

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000299

Enrollment

180

Registered

2010-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Liposomal Amphotericin B (Ambisome): Arm 1- 1omg/kg.bw -1 day. Arm 11(gr.2)- 15mg/kg bw - single dose Control Intervention1: Liposomal Amphotericin B(Ambisome): 5mg/kg/bw for four conse

Eligibility

Inclusion criteria

Inclusion criteria: Male and female of age between 08-60 years (inclusive) Clinical signs and symptoms compatible with Kala-azar (e.g.. fever, splenomegaly, anaemia, leucopenia) Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate Written informed consent from the patient/or from parent or guardian if under 18 years old

Exclusion criteria

Exclusion criteria: Safety concerns: Hemoglobin < 5 g/dl White blood cell count < 1000/mm3 Platelets <50,000 Prothrombin time > 5 sec above control ASAT > 3 times the upper limit of normal Serum creatinine or BUN > 1.5 times the upper limit of normal Malaria HIV positive serology Tuberculosis

Design outcomes

Primary

Measure	Time frame
Defined as remission of fever, decrease in spleen size by 33% compared with baseline, hemoglobin is increased by 10% compared to baseline, and improvement in other clinical signs and symptoms on day 15. Final:Defined on the fulfillment of following criteria at 6months after EOT: No relapse after initial cure, any decrease in spleen size compared with day 15, and increase of hemoglobin by 10% compared to day 15 or to at least 10g/dl.Timepoint: Six months;Defined on the fulfillment of following criteria at 6months after EOT: No relapse after initial cure, any decrease in spleen size compared with day 15, and increase of hemoglobin by 10% compared to day 15 or to at least 10g/dl.Timepoint: One year	—

Measure

Time frame

Defined as remission of fever, decrease in spleen size by 33% compared with baseline, hemoglobin is increased by 10% compared to baseline, and improvement in other clinical signs and symptoms on day 15. Final:Defined on the fulfillment of following criteria at 6months after EOT: No relapse after initial cure, any decrease in spleen size compared with day 15, and increase of hemoglobin by 10% compared to day 15 or to at least 10g/dl.Timepoint: Six months;Defined on the fulfillment of following criteria at 6months after EOT: No relapse after initial cure, any decrease in spleen size compared with day 15, and increase of hemoglobin by 10% compared to day 15 or to at least 10g/dl.Timepoint: One year

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr.Prabhat.Kumar.Sinha

ICMR

pksinha18@yahoo.com+916122635456

Outcome results