Miltefosine for Brazilian Visceral Leishmaniasis

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00378495

Enrollment

Registered

2006-09-20

Start date

2005-04-30

Completion date

2007-10-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kala Azar

Keywords

miltefosine, kala azar, Brazil

Brief summary

Miltefosine will be administered to Brazilian patients with kala azar

Detailed description

Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.

Interventions

DRUGMiltefosine: initially 2.5 mg/kg/day for 28 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture. * Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years * Sex: male and female patients eligible (no effort to be made to balance the study for gender)

Design outcomes

Primary

Measure	Time frame
cure rate at 6 months	—

Secondary

Measure	Time frame
cure rate at 1 month	—
safety	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026