Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Phase 3 Completed 667 enrolled PATH World Health Organization · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.

Timeline

Start: 2003-06
Primary completion: —
Completion: 2004-11

Outcome

Met primary endpoint

paper Paromomycin was shown to be noninferior to amphotericin B PMID 17582067 ↗

paper final cure rate, 94.6% vs. 98.8%; difference, 4.2 percentage points; upper bound of the 97.5% confidence interval, 6.9; P<0.001 PMID 17582067 ↗

Publications

Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK. Injectable paromomycin for Visceral leishmaniasis in India. N Engl J Med. 2007 Jun 21;356(25):2571-81. doi: 10.1056/NEJMoa066536.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphotericin B	Unknown	1 mg/kg	Intravenous
Subject	Paromomycin	Small molecule	11 mg/kg	Intramuscular