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Short Course Regimens for Treatment of PKDL (Sudan)

NCT03399955 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-01-18

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2021-05-09
Completion
2022-05-01

Countries

  • Sudan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03399955 on ClinicalTrials.gov