Feasibility of using single dose liposomal Amphotericin B for the treatment of Visceral Leishmaniasis in Bangladesh

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000367842
• Date of registration: 30/03/2012
• Prospective Registration: No
• Primary sponsor: World Health Organization
• Public title: Feasibility of using single dose liposomal Amphotericin B for the treatment of Visceral Leishmaniasis in Bangladesh
• Scientific title: Proof of concept to determine the feasibility of single dose liposomal Amphotericin B for the treatment of Visceral Leishmaniasis patients at Upazila level in Bangladesh
• Date of first enrolment: 12/03/2012
• Target sample size: 300
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12612000367842.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 4

Countries of recruitment

Bangladesh

Contacts

• Name: Dr. Dinesh Mondal

• Name: Dr. Dinesh Mondal

Key inclusion & exclusion criteria

Inclusion criteria: Male or female patients 5 or more years of age
History of fever for more than 2 weeks
Splenomegaly
rK 39 rapid test positive done by the study team
Hemoglobin equal or greater than 5 g/dl
Exclusion criteria: A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions not under control before starting the treatment with liposomal amphotericin B (AmBisme).
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

Age minimum: 5 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Visceral leishmaniasis;
Visceral leishmaniasis

Infection - Other infectious diseases

Public Health - Health service research

Intervention(s)

Liposomal Amphotericin B (AmBisome), single dose of 10 mg/kg, administered by intravenous infusion, over a period of approximately 2 hours.

Primary Outcome(s)

85 % of all VL patients attending the Upazila Health Center are treated with the single dose liposomal amphotericin B (AmBisome) scheme. Outcome will be calculated using the monthly medical record data and calculating the proportion of subjects diagnosed with VL that were treated with the proposed scheme.[Over the period of time required to complete the sample size.]

95% of cure rate using single dose liposomal amphotericin B (AmBisome) at Upazila Health Center

Cure rate will be calculated using the patient's medical records. Only subjects who according to the protocol fulfill the "final cure" criteria will be included.[6 months after end of treatment]

Secondary Outcome(s)

Less than 3% of patients treated with single dose liposomal amphotericin B (AmBisome) are referred to the district hospital for adverse events management.

Most adverse events expected are drug related such as fever, back pain and myalgias. The severity of an adverse event will be quantified using the Common Toxicity Criteria grading. Patient's medical records will be used to calculate the proportion of patients referred to an upper level hospital for the management of any adverse event.[Over the period of time required to treat the required number of patients]

Secondary ID(s)

Nil

Source(s) of Monetary Support

World Health Organization

Ethics review

Status: Approved
Approval date:
Contact:

World Health Organization