NCT03399955

Short Course Regimens for Treatment of PKDL (Sudan)

An Open Label, Randomized, Parallel Arm Clinical Trial of Two Regimens to Assess the Safety and Efficacy for Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) Patients in Sudan

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 6 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, randomized non comparative phase II clinical trial conducted on parallel groups, to assess the safety and efficacy of the combination of Paromomycin (20 mg/kg/d) IM for 14 days and Miltefosine (allometric dosing) oral for 42 days, and a combination of AmBisome® (20 mg/kg total dose) IV over 7 days and Miltefosine oral for 28 days (allometric dosing) for the treatment of PKDL patients in Sudan.

Conditions

• PKDL - Post-Kala-Azar Dermal Leishmanioid

Interventions

Type	Name	Description
DRUG	Paromomycin	Paromomycin (20 mg/kg/d) IM for 14 days
DRUG	Ambisome	AmBisome® (20 mg/kg total dose) IV over 7 days
DRUG	Miltefosine	Miltefosine oral (allometric dosing) for 42 days (arm 1) or 28 days (arm 2)

Timeline

• Start date: 2018-05-09
• Primary completion: 2021-05-09
• Completion: 2022-05-01
• First posted: 2018-01-17
• Last updated: 2020-01-18

Locations

1 site across 1 country: Sudan