NCT07463040

Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL)

A Multi-Arm, Multi-Stage Randomized Controlled Clinical Trial Evaluating Systemic Therapeutic Regimens for the Treatment of Cutaneous Leishmaniasis in Ethiopia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

MAMS4CL comprises a clinical trial with three embedded sub-studies designed to comprehensively evaluate the administered treatments and assess the impact of CL treatment on patients and the healthcare system. The multi-centre multi-arm multi-stage phase 3 clinical trial is designed to rigorously evaluate a total of 4 alternative treatment options for systemic CL against Sodium Stibugluconate (SSG) as the standard of care. The trial comprises two seamlessly linked stages. In stage 1, all four investigational arms will be evaluated against the control arm for efficacy to inform the selection of the arms, based on a pre-defined efficacy threshold that will advance to stage 2, in addition to the control arm. After stage 2, the experimental interventions will be compared with SSG similar to a standard superiority trial for efficacy. The general study design in stage 1 and stage 2 will be identical; only the number of investigational arms may differ. Patients will be randomized into the respective treatment arms at the recruitment sites of Arba Minch hospital, Boru Meda hospital and ALERT hospital in Ethiopia. Individuals will be hospitalized during the entire course of their treatment. As different arms have different treatment duration, patient hospitalization period and visit schedules will differ between arms. In total, the study will last 180 days for each participant.

Conditions

• Cutaneous Leihmaniasis

Interventions

Type	Name	Description
DRUG	Sodium Stibogluconate (SSG)	Intramuscular Administration - once daily for 28 days
DRUG	Miltefosine	Miltefosine - Oral Administration, daily for 28 days
DRUG	Miltefosine + Paromomycin	Miltefosine - Oral Administration, daily for 28 days + Paromomycine - Intramuscular Administration, once daily for 14 days
DRUG	Liposomal Amphotericin B (LAmB)	Intravenous Administration, once daily on days 1, 3, 5, 7, 10, 12, 14, 17, 19, 21
DRUG	Pentamidine isethionate	Intravenous Administration - once daily on days 1, 3, 5, 7, 9, 11, 13

Timeline

• Start date: 2027-01-01
• Primary completion: 2029-03-01
• Completion: 2029-08-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

3 sites across 1 country: Ethiopia