Liposomal amphotericin B for the treatment of Nepalese patients with visceral leishmaniasis.

Efficacy and safety of liposomal amphotericin B in Nepalese patients with visceral leishmaniasis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000130066

Enrollment

Registered

2010-02-09

Start date

2010-04-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Liposomal preparation of amphotericin B is found to have good efficacy (>97%) against visceral leishmaniasis in India. As there is there is no information about the use of liposomal amphotericin B in Bangladesh, this study is proposed to determine the efficacy and safety of liposomal amphotericin B in the treatment of visceral leishmaniasis in Nepalese patients. Fifthy patients will be enrolled to receive a dose of 3 mg/kg of liposomal amphotericin B for 5 consecutive days (total dose 15mg/kg) with regard to final cure rate at six months after the end of treatment.

Interventions

Liposomal amphotericin B 3mg/kg/intravenously for 5 consecutive days (total dose 15mg/kg)

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

2 Years to 65 Years

Healthy volunteers

Inclusion criteria

1 Children and adults of ages between 2 and 65 years (inclusive) 2 Fever for more than two weeks 3 Splenomegaly 4 rK39 rapid test positive 5 Confirmed diagnosis of VL by visualization of parasites on splenic aspirate 6 Biochemical and haematological test values as follows -Haemoglobin equal/greater than 6 g/dl -White blood cell count equal/ greater than 1.0 x 109/L -Platelets equal/greater than 50 x109/L -Prothrombin time equal /lower than 5 sec above control -Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) equal/lower than 3 times the upper limit of normal -Bilirubin equal/lower than 1.5 times the upper limit of normal -Serum creatinine level within normal limit 7 immunodeficiency virus antibody test (HIV) negative serology 8 Written informed consent from the patient/or from parent or guardian if under 18 years old

Exclusion criteria

1. A history of intercurrent or concurrent diseases (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or Central Nervous System (CNS) disease; diabetes mellitus, other infectious diseases or major psychiatric diseases) that may introduce variables that affect the outcome of the study 2. Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up 3. A history of allergy or hypersensitivity to Amphotericin B 4. Previous treatment for VL within two months of enrolment into the study 5. Prior treatment failure with Amphotericin B 6. Post Kala-azar Dermal Leishmaniasis (PKDL) 7. Concomitant treatment with other anti-leishmanial drugs 8. Pregnant women or lactating mother

Outcome results