Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.
1 other identifier
interventional
1,300
1 country
1
Brief Summary
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 22, 2014
March 1, 2012
2.5 years
March 27, 2012
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CLINICAL CURE
24 MONTHS
Study Arms (1)
SINGLE DOSE AMBISOME
OTHERInterventions
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Eligibility Criteria
You may qualify if:
- Male or female patients ≥ 5 years of age
- History of fever for more than 2 weeks
- Splenomegaly
- rK 39 rapid test positive
- Biochemical and hematological test values as follows:
- Hemoglobin ≥ 5 g/dl
- White blood cell count ≥1.0 x 109/L
- AST, ALT ≤ 3 times the upper limit of normal
- Serum creatinine level within normal limit
- Written informed consent from the patient/ or parent or guardian if under 18 years old.
You may not qualify if:
- A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other infectious diseases or major psychiatric diseases) only if the intercurrent conditions are not under control before starting the treatment with AmBisome.
- 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
- Prior treatment failure with Amphotericin B
- Post Kala-azar Dermal Leishmaniasis (PKDL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kala Azar Medical Research Center
Muzaffarpur, Bihar, 842001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SHYAM SUNDAR, M.D.
Banaras Hindu University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
January 22, 2014
Record last verified: 2012-03