Miltefosine for Brazilian Visceral Leishmaniasis

Phase 1

Terminated

• Conditions: Kala Azar

• Registration Number: NCT00378495
• Lead Sponsor: AB Foundation

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Study First Posted: 2006-09-20
• Primary Completion: 2007-04
• Study Completion: 2007-10
• Status Verified: 2011-01
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
cure rate at 6 months

Secondary Outcome Measures

Name	Time	Method
cure rate at 1 month
safety

Trial Locations

Locations (1)

Universidade Estadual de Montes Claros; 🇧🇷 Montes Claros, Brazil