NCT03129646

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

An Open Label, Phase III, Randomized Controlled, Multicentre Non-Inferiority Trial to Compare Efficacy and Safety of Miltefosine and Paromomycin With SSG and PM Combination for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 4 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The 2 treatment regimens to be tested are: * Arm 1: Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric dosing for 14 days * Arm 2: Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric dosing for 28 days (recruitment in this arm was discontinued under protocol v4.0 dated 22 Jul 2019) The reference arm is the current standard treatment for VL: • Arm 3: Sodium Stibogluconate 20 mg/kg/day IM/IV combined with Paromomycin 15 mg/kg/day IM for 17 days The target population will be VL patients from 4 to 50 years old in order to cover both paediatric and adult population. Patients will be hospitalized for 14 days of PM and MF treatment for both arm 1 and arm 2. MF treatment will start at the same time as PM treatment and for arm 2 it will continue on an out-patient basis until completion of the 28 days treatment. SSG\&PM combination therapy will be administered for 17 days according to routine VL treatment guidelines and patients will remain hospitalized for the entire duration of the treatment. All patients will be asked to return to the hospital for a full assessment on day 28, and for followup visits on day 56 and at six months. To respond to the objectives, study assessments will be carried out at screening and on days 1, 3, 7, 14, 21, 28, 56 (one-month post-treatment) and 210 (six-month post-treatment). These assessments will include clinical, parasitological, haematological, biochemistry, safety, pharmacokinetic and pharmacodynamics assessments.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-24
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2017-04-26
• Last updated: 2024-02-29

Locations

7 sites across 4 countries: Ethiopia, Kenya, Sudan, Uganda