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

Safety and efficacy of liposomal amphotericin B in Bangladeshi patients with visceral leishmaniasis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001029280

Enrollment

Registered

2009-11-27

Start date

2010-02-01

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 Bangladeshi patients. Thirty five 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

Intervention model

Single group

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