Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

AB Foundation

Status and phase: Completed; Phase 2

Conditions: PKDL

Treatments: Drug: Miltefosine

Study type: Interventional

Funder types: Other

Identifiers

NCT01635777

Z015

Details and patient eligibility

About

Miltefosine efficacy will be >85%

Enrollment: 37 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 years or older
• nodules and papules consistent with post kala-azar dermal leishmaniasis
• parasitological confirmation of Leishmania infection

Exclusion criteria

• platelet count <100x 109/l,
• leukocyte count <2.5 x 109/l ,
• hemoglobin < 8.0 g/100 ml ,
• liver function tests >3 times upper limit of normal range,
• bilirubin >2 times upper limit of normal range,
• serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range);
• any non-compensated or uncontrolled condition,
• lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
• treatment with any anti-leishmanial drug within the previous 12 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

12 weeks

Experimental group

Description:

miltefosine 12 weeks

Treatment:

Drug: Miltefosine

Drug: Miltefosine

8 weeks

Experimental group

Description:

miltefosine 8 weeks

Treatment:

Drug: Miltefosine

Drug: Miltefosine