Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by Banaras Hindu University
Sponsor:
Collaborator:
Rajendra Memorial Research Institute of Medical Sciences
Information provided by (Responsible Party):
Shyam Sundar, Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT01566552
First received: March 27, 2012
Last updated: January 21, 2014
Last verified: March 2012
  Purpose

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 Intervention Phase
Visceral Leishmaniasis
Drug: AMBISOME
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • CLINICAL CURE [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SINGLE DOSE AMBISOME Drug: AMBISOME
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
Other Name: LIPOSOMAL AMPHOTERECIN B

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566552

Contacts
Contact: ANUP SINGH, M.D. 09198332093 DRANUPBHU@GMAIL.COM
Contact: JAYA CHAKRAVARTY, M.D. 915422369632 TAPADAR@GMAIL.COM

Locations
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
Principal Investigator: SHYAM SUNDAR, M.D. Banaras Hindu University
  More Information

No publications provided

Responsible Party: Shyam Sundar, PROFESSOR, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT01566552     History of Changes
Other Study ID Numbers: BHU001/2012
Study First Received: March 27, 2012
Last Updated: January 21, 2014
Health Authority: India: Indian Council of Medical Research
India: Drugs Controller General of India

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

Additional relevant 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
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 18, 2014