Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT00371995
Eligibility Criteria:
Inclusion Criteria:
* Male and female age between 2 and 65 years (inclusive)
* Parasites visualized on splenic aspiration
* Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
* Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
* Fever for at least 2 weeks
* Written informed consent from the patient/or from parent or guardian if under 18 years old
Exclusion Criteria:
* Hemoglobin \< 6 g/dl
* White blood cell count \< 1000/mm3
* Platelets \<50,000
* Prothrombin time \> 5 sec above control
* ASAT \> 3 times the upper limit of normal
* Serum creatinine or BUN \> 1.5 times the upper limit of normal
* Malaria
* Tuberculosis
* HIV positive serology
* Lactation, pregnancy
* Refusing contraception method during treatment period plus 3 months
* Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs
* Any concomitant drug that is nephrotoxic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
65 Years
Study:
NCT00371995
Study Brief:
Protocol Section:
NCT00371995