Miltefosine for Brazilian Visceral Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378495
Recruitment Status : Terminated (accrual criteria being reviewed)
First Posted : September 20, 2006
Last Update Posted : July 12, 2016
AEterna Zentaris
Information provided by:
AB Foundation

September 18, 2006
September 20, 2006
July 12, 2016
April 2005
April 2007   (Final data collection date for primary outcome measure)
cure rate at 6 months
Same as current
Complete list of historical versions of study NCT00378495 on Archive Site
  • cure rate at 1 month
  • safety
Same as current
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Miltefosine for Brazilian Visceral Leishmaniasis
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Miltefosine will be administered to Brazilian patients with kala azar
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.
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kala Azar
Drug: Miltefosine: initially 2.5 mg/kg/day for 28 days
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2007
April 2007   (Final data collection date for primary outcome measure)

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)

Exclusion Criteria:

Exclusion criteria

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;
  • Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria).

Administrative reasons:

  • Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);
  • Anticipated non-availability for study visits/procedures.
Sexes Eligible for Study: All
2 Years to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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AB Foundation
AEterna Zentaris
Principal Investigator: Reynaldo Dietze Núcleo de Doenças Infecciosas - UFES
AB Foundation
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP