NCT00378495

Brief Summary

Miltefosine will be administered to Brazilian patients with kala azar

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

July 12, 2016

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

September 18, 2006

Last Update Submit

July 11, 2016

Conditions

Kala Azar

Keywords

miltefosinekala azarBrazil

Outcome Measures

Primary Outcomes (1)

  • cure rate at 6 months

Secondary Outcomes (2)

  • cure rate at 1 month

  • safety

Interventions

Miltefosine: initially 2.5 mg/kg/day for 28 daysDRUG

Eligibility Criteria

Age2 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Safety concerns:
  • Thrombocyte count \<30 x 109/l;
  • Leukocyte count \<1 x 109/l;
  • Hemoglobin \<5 g/100 ml;
  • ASAT, ALAT, AP \>3 times upper limit of normal range;
  • Serum creatinine or BUN \>1.5 times upper limit of normal range;
  • Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary);
  • Immunodeficiency or antibody to HIV;
  • Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus);
  • Any non-compensated or uncontrolled condition;
  • Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months.
  • Lack of suitability for the trial:
  • Negative bone marrow aspirate (smear);
  • Any history of prior anti-leishmania therapy;
  • Any condition which compromises ability to comply with the study procedures;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual de Montes Claros

Montes Claros, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Reynaldo Dietze

    Núcleo de Doenças Infecciosas - UFES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 20, 2006

Study Start

April 1, 2005

Primary Completion

April 1, 2007

Study Completion

October 1, 2007

Last Updated

July 12, 2016

Record last verified: 2011-01

Locations

BR(1)