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Safety and efficacy of liposomal amphotericin B (Ambisome) in patients with post kala-azar dermal leishmaniasis(PKDL).

"Safety and efficacy of liposomal amphotericin B (Ambisome) in patients with post kala-azar dermal leishmaniasis(PKDL)".

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000159
Enrollment
50
Registered
2010-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Liposomal Amphotericin B: Control Intervention1: NIL: N/A

Sponsors

RMRIMS(ICMR).
Lead Sponsor

Eligibility

Inclusion 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: 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 diseases Lack of suitability for the trial: ? Concomitant treatment with other anti-leishmaniasis drugs

Design outcomes

Primary

MeasureTime frame
Efficacy variable:Presence of parasites in slit-skin or skin snip smears. Safety variables: - Vital parameters ? Laboratory (hemogram, clinical chemistry) 8.6 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 plaques Safety variables: - Vital parameters ? Laboratory (hemogram, clinical chemistry) Overall assessment: - Study outcome / response to therapy 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: Efficacy variable: - Presence of parasites in slit-skin or snip skin smears, skin biopsy - Clinical picture of papules, nodules and plaques Safety variables: - Vital parameters ? Laboratory (hemogram, clinical chemistry) Overall assessment: - Study outcome / response to therapy—

Secondary

MeasureTime frame
Disappearnce of clinical picture of papules, nodules and plaques.Timepoint: 12 months—

Countries

India

Contacts

Public ContactDr.Prabhat Kumar Sinha

Indian Council of Medical Research.

pksinha18@yahoo.com06122635456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026