Miltefosine for Brazilian Visceral Leishmaniasis
This study has been terminated.
(accrual criteria being reviewed)
Information provided by:
First received: September 18, 2006
Last updated: January 18, 2011
Last verified: January 2011
Miltefosine will be administered to Brazilian patients with kala azar
Drug: Miltefosine: initially 2.5 mg/kg/day for 28 days
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
Secondary Outcome Measures:
- cure rate at 1 month
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2007 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||2 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);
- Anticipated non-availability for study visits/procedures.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378495
|Universidade Estadual de Montes Claros
|Montes Claros, Brazil |
||Núcleo de Doenças Infecciosas - UFES
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 18, 2006
||January 18, 2011
||Brazil: National Committee of Ethics in Research
Keywords provided by AB Foundation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014