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Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis

NCT01566552 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2014-01-22

No results posted yet for this study

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.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

AMBISOME

SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS

Sponsors & Collaborators

  • Rajendra Memorial Research Institute of Medical Sciences

    collaborator OTHER

  • Banaras Hindu University

    lead OTHER

Principal Investigators

  • SHYAM SUNDAR, M.D. · Banaras Hindu University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566552 on ClinicalTrials.gov