Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis

January 21, 2014 updated by: Shyam Sundar, Banaras Hindu University

Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Bihar
      • Muzaffarpur, Bihar, India, 842001
        • Kala Azar Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patients ≥ 5 years of age
  2. History of fever for more than 2 weeks
  3. Splenomegaly
  4. rK 39 rapid test positive

  5. 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
  6. Written informed consent from the patient/ or parent or guardian if under 18 years old.

Exclusion Criteria:

  1. 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.
  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
  5. Prior treatment failure with Amphotericin B
  6. Post Kala-azar Dermal Leishmaniasis (PKDL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: SINGLE DOSE AMBISOME
Drug: AMBISOME
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Other Names:
  • LIPOSOMAL AMPHOTERECIN B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
CLINICAL CURE
Time Frame: 24 MONTHS
24 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Banaras Hindu University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rajendra Memorial Research Institute of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SHYAM SUNDAR, M.D., Banaras Hindu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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