Miltefosine for Brazilian Visceral Leishmaniasis

AB Foundation

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Kala Azar

Treatments

Drug: Miltefosine: initially 2.5 mg/kg/day for 28 days

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00378495

D-18506-Z019

Details and patient eligibility

About

Miltefosine will be administered to Brazilian patients with kala azar

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

2 to 65 years old

Volunteers

No 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)

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.