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

Phase 2

Completed

• Conditions: PKDL
• Interventions: Drug: Miltefosine

• Registration Number: NCT01635777
• Lead Sponsor: AB Foundation

Brief Summary

Miltefosine efficacy will be \>85%

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-10
• Study Completion: 2010-12
• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-09
• Last Update Submitted: 2012-07-09
• Study First Posted: 2012-07-10
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 weeks	Miltefosine	miltefosine 8 weeks
12 weeks	Miltefosine	miltefosine 12 weeks

Primary Outcome Measures

Name	Time	Method
Cure rate	12 months after end of treatment

Secondary Outcome Measures

Name	Time	Method
adverse events	during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group	gastrointestinal events: vomiting and diarrhea

Trial Locations

Locations (1)

Institute of Medical Sciences, Banaras Hindu University,; 🇮🇳 Varanasi, India