Feasibility of using single dose liposomal Amphotericin B for the treatment of Visceral Leishmaniasis in Bangladesh

Phase 4

Recruiting

• Conditions: Visceral leishmaniasis; Public Health - Health service research; Infection - Other infectious diseases

• Registration Number: ACTRN12612000367842
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Male or female patients 5 or more years of age
History of fever for more than 2 weeks
Splenomegaly
rK 39 rapid test positive done by the study team
Hemoglobin equal or greater than 5 g/dl

Exclusion Criteria

A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions not under control before starting the treatment with liposomal amphotericin B (AmBisme).
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 within two months of enrolment into the study
Prior treatment failure with amphotericin B

Study & Design

• Study Type: Interventional
• Study Design: Not specified