- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01566552
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.
Study Overview
Detailed Description
Primary Objectives:
To evaluate the operational feasibility of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome® single dose of 10 mg/kg, when administrated at the Primary Health Centers (PHC) setting with regard to feasibility and safety .
Secondary objectives:
To determine efficacy of the treatment scheme when delivered by district hospitals and PHC facilities
Methodology:
Three districts, Saran, Simastipur and Muzaffarpur in the VL endemic state of Bihar in India will be selected for the study. Initially, 300 eligible patients will be diagnosed and treated at hospital level with liposomal amphotericin B, using a single dose of 10 mg/kg. If no significant feasibility or safety issues are identified in this group of patients, 1000 additional subjects will be diagnosed and treated at the PHC level. Feasibility will be determined by the proportion of patients attending the PHCs treated with single dose AmBisome and the proportion of patients that need to be referred to the district hospitals for management of adverse events. The initial cure rate will be determined at day 30, after end of treatment (EOT). If initial cure is observed, the patient will be followed up and evaluated 6 months after the end of treatment for final clinical cure.
Study medication, dose and mode of administration Liposomal Amphotericin B (Gilead Sciences, Foster City, CA, USA) is formulated as a lyophilized powder which will be reconstituted in 10 ml of distilled water as a solution and the total dose will be then diluted in three times the volume of 5% dextrose solution.
Total infusion will be done in 2 hours.
Before infusion of AmBisome®, each patient will be given Paracetamol (Adult: 500 mg; Children below 12 years 10 mg/kg) and Chlorpheniramine (Adult: 4mg; Children below 12 years 1-2mg)
Parameters for evaluation Laboratory parameters for safety Adverse event
Endpoints (Feasibility)
- 85% of VL patients attending the PHCs are treated with the single dose AmBisome scheme.
- 3% of patients treated with single dose AmBisome are referred to district hospitals for AEs management .
- 95% of patients treated with single dose AmBisome are cure at 6 months after EOT.
Endpoints (Efficacy) Initial Cure: Defined as remission of fever, any decrease in spleen size compared with baseline, hemoglobin is increased by at least 10% compared to baseline or to at least 10g/dl, and improvement in other clinical signs and symptoms on day 30.
Final Cure: Defined on the fulfillment of following criteria at 6 months after EOT: No relapse after initial cure, absence of fever and no increase in spleen size compared with day 30 and hemoglobin is increased by at least10% compared to day 30 or to at least 10g/dl.
Statistical methods Efficacy analysis: Calculation of cure rate with 95% and 90% lower confidence limit according to the Clopper Pearson method.
Safety analysis: Calculation of overall incidence of adverse events.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Bihar
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Muzaffarpur, Bihar, India, 842001
- Kala Azar Medical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: SINGLE DOSE AMBISOME
|
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CLINICAL CURE
Time Frame: 24 MONTHS
|
24 MONTHS
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: SHYAM SUNDAR, M.D., Banaras Hindu University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Visceral
- Anti-Infective Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Liposomal amphotericin B
Other Study ID Numbers
- BHU001/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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