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Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa

NCT03129646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2024-02-29

No results posted yet for this study

Summary

This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult and children VL patients in Eastern Africa.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Miltefosine

Miltefosine 10mg and 50mg capsules

DRUG

Paromomycin

Paromomycin sulfate equiv to 750mg paromomycin / 2ml amp

DRUG

Sodium stibogluconate

Sodium stibogluconate 33% 30 ml inj.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • The Institute of Endemic Diseases (IEND), University of Khartoum

    collaborator UNKNOWN

  • Kenya Medical Research Institute

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • University of Gondar

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Jane Mbui, MD · Kenya Medical Research Institute

  • Joseph Olobo, MD, Prof · College of Health Sciences, Makerere University, Uganda

  • Ahmed M Musa, MD, Prof · Institute of Endemic Diseases, Sudan

  • Rezika Mohammed, MD · University Hospital of Gondar, Ethiopia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2020-12-11
Completion
2020-12-11

Countries

  • Ethiopia
  • Kenya
  • Sudan
  • Uganda

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 NCT03129646 on ClinicalTrials.gov