Safety and effectiveness of Liposomal Amphotericin B (AmBisome) Vs Miltefosine in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL)

Assessment of Safety,efficacy of Liposomal Amphotericin B (AmBisome) Vs Miltefosine 12 weeks therapy in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL)-an observational pilot study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014015

Enrollment

100

Registered

2018-05-21

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

Health Condition 1: null- Post Kalaazar Dermal Leishmaniasis(PKDL)

Interventions

Intervention1: Liposomal Amphotericin B(AmBisome): AmBisome at a total dose of 30 mg/kg, 5 mg/kg biweekly for 3 weeks Control Intervention1: Miltefosine: Miltefosine in the dose of 2.5mg/kg/day or 100

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients aged 5- 65 years Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis. Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies and qPCR)

Exclusion criteria

Exclusion criteria: Pregnant and lactating female Patients not willing to participate. Thrombocyte count Leukocyte count Hemoglobin ASAT, ALAT, AP >3 times upper limit of normal range Bilirubin >2 times upper limit of normal range HbsAg, HCV and HIV positive Serum creatinine or BUN >1.5 times upper limit of normal range Hypersensitivity to AmBisome or inactive ingredients of AmBisome and Miltefosine. Patients not willing to take contraceptive measures during study duration.

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients. Timepoint: To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients.	—

Secondary

Measure	Time frame
To assess the adverse events and serious adverse events of the two different regimens To assess the rates of relapse after initial response To evaluate the biochemical and haematological parameters during the course of treatment. Timepoint: 12 months after the end of treatment.	—

Countries

India

Contacts

Public ContactDrKrishna Pandey

Clinical Medicine, RMRIMS

drkrishnapandey@yahoo.com

Outcome results

None listed

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