"Safety and efficacy of liposomal amphotericin B (Ambisome) in patients with post kala-azar dermal leishmaniasis(PKDL)".
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Efficacy variable:Presence of parasites in slit-skin or skin snip smears. Safety variables:- Vital parameters? Laboratory (hemogram, clinical chemistry)8.6Assessments after 12 months follow upEfficacy variable:- Presence of parasites in slit-skin or snip skin smears, skin biopsyClinical picture of papules, nodules and plaquesSafety variables:- Vital parameters? Laboratory (hemogram, clinical chemistry)Overall assessment:- Study outcome / response to therapyFor 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.
Study Overview
Brief Summary
This is open label stidy to assess the efficacy and safety of liposomal amphotericin B regimens 2.5 mg/kg/bw for 20 consecutive days duration for their curative potential in PKDL (parameter: rate of patients with macular/nodular and papular lesions who achieve negative parasitology and clinical severity score of zero 12 months after end of treatment).
Study Design
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria:?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.
Exclusion Criteria
- •Exclusion criteria: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 diseasesLack of suitability for the trial:?Concomitant treatment with other anti-leishmaniasis drugs.
Outcomes
Primary Outcomes
Efficacy variable:Presence of parasites in slit-skin or skin snip smears. Safety variables:- Vital parameters? Laboratory (hemogram, clinical chemistry)8.6Assessments after 12 months follow upEfficacy variable:- Presence of parasites in slit-skin or snip skin smears, skin biopsyClinical picture of papules, nodules and plaquesSafety variables:- Vital parameters? Laboratory (hemogram, clinical chemistry)Overall assessment:- Study outcome / response to therapyFor 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.
Time Frame: Assessments after 12 months follow up:Efficacy variable:- Presence of parasites in slit-skin or snip skin smears, skin biopsy- Clinical picture of papules, nodules and plaquesSafety variables:- Vital parameters? Laboratory (hemogram, clinical chemistry)Overall assessment:- Study outcome / response to therapy
Secondary Outcomes
- Disappearnce of clinical picture of papules, nodules and plaques.(12 months)