Miltefosine for Brazilian Visceral Leishmaniasis (NCT00378495) | Clinical Trial Compass
TerminatedPhase 1/2
Miltefosine for Brazilian Visceral Leishmaniasis
Stopped: accrual criteria being reviewed
Brazil80 participantsStarted 2005-04
Plain-language summary
Miltefosine will be administered to Brazilian patients with kala azar
Who can participate
Age range
2 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 / le…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.