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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00371995 |
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Date of registration:
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05/09/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
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Scientific title:
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The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00371995 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Shyam Sundar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Banaras Hindu University |
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Name:
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Prabhat K Sinha, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rajendra Memorial Research Institute of Medical Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Visceral Leishmaniasis
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Intervention(s)
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Drug: Liposomal amphotericin B and Miltefosine
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Primary Outcome(s)
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Final Cure six months after the end of treatment
[Time Frame: 1 year]
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Secondary ID(s)
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LEI PDE 06 03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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