Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000130066
Ethics application status
Approved
Date submitted
6/02/2010
Date registered
9/02/2010
Date last updated
9/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Liposomal amphotericin B for the treatment of Nepalese patients with visceral leishmaniasis.
Scientific title
Efficacy and safety of liposomal amphotericin B in Nepalese patients with visceral leishmaniasis.
Secondary ID [1] 253018 0
A90184
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visceral Leishmaniasis 256765 0
Condition category
Condition code
Infection 256917 256917 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Liposomal amphotericin B
3mg/kg/intravenously for 5 consecutive days (total dose 15mg/kg)
Intervention code [1] 255977 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257790 0
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)
Timepoint [1] 257790 0
Six months after end of treatment
Secondary outcome [1] 263199 0
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.
Timepoint [1] 263199 0
During treatment, at end of treatment and at six months after end of treatment

Eligibility
Key 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
Minimum age
2 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
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
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 2469 0
Nepal
State/province [1] 2469 0
Khatmandu

Funding & Sponsors
Funding source category [1] 256476 0
Other Collaborative groups
Name [1] 256476 0
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)
Country [1] 256476 0
Switzerland
Primary sponsor type
Other Collaborative groups
Name
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)
Address
20 Appia Avenue
1211, Geneva 27
Country
Switzerland
Secondary sponsor category [1] 255784 0
None
Name [1] 255784 0
Address [1] 255784 0
Country [1] 255784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258527 0
Nepal Health Research Council
Ethics committee address [1] 258527 0
Ethics committee country [1] 258527 0
Nepal
Date submitted for ethics approval [1] 258527 0
Approval date [1] 258527 0
04/12/2009
Ethics approval number [1] 258527 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30810 0
Address 30810 0
Country 30810 0
Phone 30810 0
Fax 30810 0
Email 30810 0
Contact person for public queries
Name 14057 0
Professor Dr Suman Rijal
Address 14057 0
Department of Internal Medicine
B P Koirala Institute of Health Sciences,
Dharan, Nepal P.O. Box 7053
Country 14057 0
Nepal
Phone 14057 0
+977 25 531254
Fax 14057 0
+977 25 531253
Email 14057 0
[email protected]
Contact person for scientific queries
Name 4985 0
Professor Dr Suman Rijal
Address 4985 0
Department of Internal Medicine
B P Koirala Institute of Health Sciences,
Dharan, Nepal P.O. Box 7053
Country 4985 0
Nepal
Phone 4985 0
+977 25 531254
Fax 4985 0
+977 25 531253
Email 4985 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.