Safety and efficacy of liposomal amphotericin B (Ambisome) in patients with post kala-azar dermal leishmaniasis(PKDL).
- Registration Number
- CTRI/2010/091/000159
- Lead Sponsor
- RMRIMS(ICMR).
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
?Male or female patient aged 5 years or older
?Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies)
?Nodules, papules or plaques as clinical signs consistent with post kala azar dermal leishmaniasis.
Safety concerns:
?Thrombocyte count <100 x 109/l
?Leukocyte count <1.5 x 109/l
?Hemoglobin < 5.0 g/100 ml
?ASAT, ALAT, AP >3 times upper limit of normal range
?Bilirubin >2 times upper limit of normal range
?Serum creatinine or BUN >1.5 times upper limit of normal range
?Major surgery within last 2 weeks
?Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
Lack of suitability for the trial:
?Concomitant treatment with other anti-leishmaniasis drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy variable:Presence of parasites in slit-skin or skin snip smears. <br> <br>Safety variables:- Vital parameters<br>? Laboratory (hemogram, clinical chemistry)<br>8.6Assessments after 12 months follow up<br>Efficacy variable:- Presence of parasites in slit-skin or snip skin smears, skin biopsy<br>Clinical picture of papules, nodules and plaques<br>Safety variables:- Vital parameters<br>? Laboratory (hemogram, clinical chemistry)<br>Overall assessment:- Study outcome / response to therapy<br><br>For the rates of definite and apparent cures 95%-lower confidence bounds will be calculated. The primary analysis will be based on the intent to treat population.Timepoint: Assessments after 12 months follow up:<br>Efficacy variable:- Presence of parasites in slit-skin or snip skin smears, skin biopsy<br>- Clinical picture of papules, nodules and plaques<br>Safety variables:- Vital parameters<br>? Laboratory (hemogram, clinical chemistry)<br>Overall assessment:- Study outcome / response to therapy<br>
- Secondary Outcome Measures
Name Time Method Disappearnce of clinical picture of papules, nodules and plaques.Timepoint: 12 months