ActivePhase 2Phase 3ACTRN12609001029280

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

Sponsor

The United Nations Children's Fund (UNICEF)/ The United Nations Development Programme (UNDP) /World Bank /World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR)

Enrollment

35 participants

Start Date

Feb 1, 2010

Study Type

Interventional

Conditions

Visceral leishmaniasis (VL)

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.

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 65 Yearss

Inclusion Criteria15

Children and adults of ages between 2 and 65 years (inclusive)
Fever for more than two weeks
Splenomegaly
rK39 rapid test positive
Confirmed diagnosis of VL by visualization of parasites on splenic aspirate
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
immunodeficiency virus antibody test (HIV) negative serology
Written informed consent from the patient/or from parent or guardian if under 18 years old

Exclusion Criteria8

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
Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
A history of allergy or hypersensitivity to Amphotericin B
Previous treatment for VL within two months of enrolment into the study
Prior treatment failure with Amphotericin B
Post Kala-azar Dermal Leishmaniasis (PKDL)
Concomitant treatment with other anti-leishmanial drugs
Pregnant women or lactating mother

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Interventions

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

Locations(1)

Mymensingh, Bangladesh

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ACTRN12609001029280