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Trial registered on ANZCTR


Registration number
ACTRN12612000367842
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
30/03/2012
Date last updated
28/03/2013
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 280192 0
Nil
Universal Trial Number (UTN)
U1111-1129-3680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visceral leishmaniasis 286127 0
Condition category
Condition code
Public Health 286318 286318 0 0
Health service research
Infection 286410 286410 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Liposomal Amphotericin B (AmBisome), single dose of 10 mg/kg, administered by intravenous infusion, over a period of approximately 2 hours.
Intervention code [1] 284517 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286788 0
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.
Timepoint [1] 286788 0
Over the period of time required to complete the sample size.
Primary outcome [2] 286789 0
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.
Timepoint [2] 286789 0
6 months after end of treatment
Secondary outcome [1] 296660 0
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.
Timepoint [1] 296660 0
Over the period of time required to treat the required number of patients

Eligibility
Key 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
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who spontaneously come to the Upazila Health Center for diagnosis or treatment of visceral leishmaniasis, or those who are identified by the active case detection system run by the national program and are referred from the community to the Upazila Health Center who, according to the Upazila Health Center medical officer, is eligible for the study will be be treated with single dose of liposomal amphotericin B (AMBisome)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4212 0
Bangladesh
State/province [1] 4212 0
Mymensingh

Funding & Sponsors
Funding source category [1] 284940 0
Other
Name [1] 284940 0
World Health Organization
Address [1] 284940 0
20 Avenue Appia
1211, Geneva 27
Country [1] 284940 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
20 Avenue Appia
1211, Geneva 27
Country
Switzerland
Secondary sponsor category [1] 283814 0
None
Name [1] 283814 0
Address [1] 283814 0
Country [1] 283814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286949 0
World Health Organization
Ethics committee address [1] 286949 0
20 Avenue Appia
1211, Geneva 27
Ethics committee country [1] 286949 0
Switzerland
Date submitted for ethics approval [1] 286949 0
Approval date [1] 286949 0
01/12/2011
Ethics approval number [1] 286949 0

Summary
Brief summary
The study is designed to determine the use of delivering treatment with liposomal amphotericin B (AmBisome) single dose of 10 mg/kg when administrated in the Upazila Health Complex settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33958 0
Address 33958 0
Country 33958 0
Phone 33958 0
Fax 33958 0
Email 33958 0
Contact person for public queries
Name 17205 0
Dr. Dinesh Mondal
Address 17205 0
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Mohakhali, Dhaka-1212, Bangladesh
Country 17205 0
Bangladesh
Phone 17205 0
+880-2-8860523
Fax 17205 0
+880-2-8812529
Email 17205 0
din63d@icddrb.org
Contact person for scientific queries
Name 8133 0
Dr. Dinesh Mondal
Address 8133 0
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Mohakhali, Dhaka-1212, Bangladesh
Country 8133 0
Bangladesh
Phone 8133 0
+880-2-8860523
Fax 8133 0
+880-2-8812529
Email 8133 0
din63d@icddrb.org

No information has been provided regarding IPD availability
Summary results
No Results