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.
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)
35 participants
Apr 1, 2010
Interventional
Conditions
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.
Eligibility
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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Liposomal amphotericin B 3mg/kg/intravenously for 5 consecutive days (total dose 15mg/kg)
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12610000130066