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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609001029280
• Date of registration: 27/11/2009
• Prospective Registration: Yes
• Primary 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)
• Public title: Liposomal amphotericin B for the treatment of Bangladeshi patients with visceral leishmaniasis.
• Scientific title: Safety and efficacy of liposomal amphotericin B in Bangladeshi patients with visceral leishmaniasis
• Date of first enrolment: 01/02/2010
• Target sample size: 35
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12609001029280.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Bangladesh

Contacts

• Name: Prof. Mahmudur Rahman

• Name: Prof. Mahmudur Rahman

Key inclusion & exclusion criteria

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

Age minimum: 2 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Visceral leishmaniasis (VL);
Visceral leishmaniasis (VL)

Intervention(s)

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

Primary Outcome(s)

Efficacy of liposomal amphotericin B in a daily dose of 3mg/kg body weight for 5 consecutive days. Efficacy will be based on clinical response (No fever, weight gain = 0.5 kg compared with baseline, and any decrease in spleen size compared with baseline), laboratory findings (Increase of haemoglobin by 10% compared to baseline or to at least 10g/dl) and parasitological assessment (eradication of parasite at day 19 or 45 after end of treatment)[At six months after end of treatment]

Secondary Outcome(s)

To assess the safety of liposomal amphotericin B when administered in the proposed dosage regimen. Safety will be assess by recording and calculation of overall incidence of all adverse events which is defined as any unfavorable and unintended sign including an abnormal laboratory (or vital, etc.) finding, symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.[During treatment, at end of treatment and at six months after end of treatment.]

Secondary ID(s)

A80460 Special Programme for Research and Training in Tropical Diseases (TDR) / World Health Organization (WHO)

Source(s) of Monetary Support

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)

Ethics review

Status: Approved
Approval date:
Contact:

Bangladesh Medical Research Council