Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01566552
Recruitment Status : Unknown
Verified March 2012 by Shyam Sundar, Banaras Hindu University.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2012
Last Update Posted : January 22, 2014
Sponsor:
Collaborator:
Rajendra Memorial Research Institute of Medical Sciences
Information provided by (Responsible Party):
Shyam Sundar, Banaras Hindu University

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.

Condition or disease Intervention/treatment Phase
Visceral Leishmaniasis Drug: AMBISOME Phase 4

  Hide Detailed Description

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.
Study Start Date : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
SINGLE DOSE AMBISOME Drug: AMBISOME
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Other Name: LIPOSOMAL AMPHOTERECIN B




Primary Outcome Measures :
  1. CLINICAL CURE [ Time Frame: 24 MONTHS ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566552


Contacts
Layout table for location contacts
Contact: ANUP SINGH, M.D. 09198332093 DRANUPBHU@GMAIL.COM
Contact: JAYA CHAKRAVARTY, M.D. 915422369632 TAPADAR@GMAIL.COM

Locations
Layout table for location information
India
Kala Azar Medical Research Center Not yet recruiting
Muzaffarpur, Bihar, India, 842001
Contact: DEEPAK VERMA, MBBS    916212287570    KMARCMFP@HOTMAIL.COM   
Sponsors and Collaborators
Banaras Hindu University
Rajendra Memorial Research Institute of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: SHYAM SUNDAR, M.D. Banaras Hindu University

Layout table for additonal information
Responsible Party: Shyam Sundar, PROFESSOR, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT01566552     History of Changes
Other Study ID Numbers: BHU001/2012
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: March 2012

Keywords provided by Shyam Sundar, Banaras Hindu University:
AMBISOME
VISCERAL LEISHMANIASIS
SINGLE DOSE

Additional relevant MeSH terms:
Layout table for MeSH terms
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents