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

Phase 3 Completed 439 enrolled Drugs for Neglected Diseases Kenya Medical Research Institute · collab Makerere University · collab The Institute of Endemic Diseases (IEND), University of Khartoum · collab The Netherlands Cancer Institute · collab University of Gondar · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Publications

Musa AM, Mbui J, Mohammed R, Olobo J, Ritmeijer K, Alcoba G, Muthoni Ouattara G, Egondi T, Nakanwagi P, Omollo T, Wasunna M, Verrest L, Dorlo TPC, Musa Younis B, Nour A, Taha Ahmed Elmukashfi E, Ismail Omer Haroun A, Khalil EAG, Njenga S, Fikre H, Mekonnen T, Mersha D, Sisay K, Sagaki P, Alvar J, Solomos A, Alves F. Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa: A Randomized, Controlled, Multicountry Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1177-e1185. doi: 10.1093/cid/ciac643.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Miltefosine	Small molecule	—	Oral
Subject	Paromomycin	Small molecule	15 mg/kg	Intramuscular
Subject	Paromomycin	Small molecule	20 mg/kg	Intramuscular
Comparator	sodium stibogluconate	Unknown	20 mg/kg	Intramuscular

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

Summary

Timeline

Publications

Drugs

Indications